7899Wednesday, May 22, 2013Rules and RegulationsDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration21 CFR Part 520[Docket No. FDA-2013-N-0002]Oral Dosage Form New Animal Drugs; Clindamycin; EnrofloxacinAGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2013. FDA is also informing the public of the availability of summaries for the basis of approval and of environmental review documents, where applicable.

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April 2013, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room:http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Table 1—Original and Supplemental NADAs and ANADAs Approved During April 2013NADA/

ANADA

SponsorNew animal drug product nameAction21 CFR SectionFOIA

summary

NEPA

review

200-538Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, IrelandCLINDAMED (clindamycin hydrochloride) Oral DropsOriginal approval as a generic copy of NADA 135-940520.447yesCE1.200-551Putney, Inc., 400 Congress St., Suite 200, Portland, ME 04101Enrofloxacin Flavored TabletsOriginal approval as a generic copy of NADA 140-441520.812yesCE1.1The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human environment.List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS1. The authority citation for 21 CFR part 520 continues to read as follows:Authority:

On May 19, 2010, the Secretary of the Interior separated and reassigned responsibilities previously performed by the former Minerals Management Service (MMS) to three separate organizations. As part of this reorganization, on October 1, 2010, the Secretary established the Office of Natural Resources Revenue (ONRR) within the Office of the Assistant Secretary—Policy, Management and Budget (PMB). At the same time, ONRR initiated a CFR chapter reorganization. This direct final rule amends the remaining Office of Management and Budget (OMB) approved form numbers for information collection requirements and corresponding technical corrections to part and position titles, agency names, and acronyms.

DATES:

This rule is effective on May 22, 2013.

FOR FURTHER INFORMATION CONTACT:

For questions on technical issues, contact Armand Southall, Regulatory Specialist, ONRR, telephone (303) 231-3221; or emailarmand.southall@onrr.gov.You may obtain a paper copy of this rule by contacting Mr. Southall by phone or email.

SUPPLEMENTARY INFORMATION:I. Background

On May 19, 2010, by Secretarial Order No. 3299, the Secretary of the Department of the Interior (Secretary) announced the restructuring of MMS. On June 18, 2010, by Secretarial Order No. 3302, the Secretary announced the name change of MMS to the Bureau of Ocean Energy Management, Regulation, and Enforcement (BOEMRE). By these orders, the Secretary separated and reassigned the responsibilities previously performed by the former MMS to three separate organizations: the Office of Natural Resources Revenue, the Bureau of Ocean Energy Management (BOEM), and the Bureau of Safety and Environmental Enforcement (BSEE). ONRR is responsible for the royalty management functions of the former MMS's Minerals Revenue Management Program.

II. Explanation of Amendments

In this direct final rule, ONRR merely amends its remaining OMB-approved form numbers for information collection requests listed in certain parts of title 30 CFR, chapter XII. ONRR does not make any substantive changes in this direct final rule to the regulations or requirements in chapter XII. We also merely make any necessary corresponding technical corrections to part and position titles, agency names, and acronyms. This rule will not have any effect on the rights, obligations, or interests of any affected parties. Thus, under 5 U.S.C. 553(b)(B), ONRR, for good cause, finds that notice and comment on this rule are unnecessary and contrary to the public interest. Additionally, because this document is a “rule(. . .) of agency organization, procedure or practice” under 5 U.S.C. 553(b)(A), this document is, in any event, exempt from the notice and comment requirements of 5 U.S.C. 553(b). Lastly, because this non-substantive rule makes no changes to the legal obligations or rights of any affected parties, and because it is in the public interest for this rule to be effective as soon as possible, ONRR finds that good cause exists under 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in theFederal Registerrather than 30 days after publication.

As noted, this direct final rule amends the following 30 CFR parts and the related existing subparts:

• Part 1202—Royalties

• Part 1204—Alternatives for Marginal Properties

• Part 1206—Product Valuation

• Part 1207—Sales Agreements or Contracts Governing the Disposal of Lease Products

• Part 1210—Forms and Reports

• Part 1218—Collection of Royalties, Rentals, Bonuses, and Other Monies Due the Federal Government

The following sections explain further these amendments to the regulations:

Subchapter A—Natural Resources RevenueA. Part 1202—Royalties

We are revising part 1202, subparts C, D, and H.

Acronyms, Agency Names, OMB-approved Form Numbers, and Section Numbers.We are amending sections to replace “Bureau of Ocean Energy Management, Regulations, and Enforcement” with “Bureau of Ocean Energy Management” or “Bureau of Safety and Environmental Enforcement” and “BOEMRE” with “BOEM” or “BSEE,” respectively. We also are amending our OMB-approved form numbers, listed in this part, to replace “MMS” with “ONRR” as we complete our form update process. In addition, we are correcting a misprinted section number from § 202.350 to § 1202.350 due to reorganizing and repromulgating our regulations in chapter XII, title 30 CFR.

B. Part 1204—Alternatives for Marginal Properties

We are revising part 1204, subpart C.

Acronym, OMB-approved Form Numbers, and Section Numbers.We are updating this subpart to replace references of “BOEMRE” with “BOEM.” We also are amending OMB-approved form numbers, listed in this part, to replace “MMS” with “ONRR” as we complete our form-update process. We also are revising § 1204.215 in Plain Language to meet the criteria of Executive Orders 12866 and 12988, and the Presidential Memorandum dated June 1, 1998, which require us to write all rules so that the public can read them more clearly and consistently. This revision makes no substantive changes as previously stated in Section II, Explanation of Amendments, of this rule. In addition, we are correcting referenced section numbers due to reorganizing and repromulgating our regulations in chapter XII, title 30 CFR.

C. Part 1206—Product Valuation

We are revising part 1206, subparts B, C, D, E, F, H, and J.

Acronyms, Definitions, OMB-approved Form Numbers, and Section Numbers.We are amending the OMB-approved form numbers, listed in this part, to replace “MMS” with “ONRR” as we complete our form-update process. We also are amending this part to replace references of “BOEMRE” with “BOEM” or “BSEE,” depending on the context. We also are adding new definitions, “BOEM” and “BSEE,” into §§ 1206.101 and 1206.151 and amending § 1206.364(d) to remove “subpart B.” In addition, we arecorrecting referenced part and section numbers due to reorganizing and repromulgating our regulations in chapter XII, title 30 CFR.

D. Part 1207—Sales Agreements or Contracts Governing the Disposal of Lease Products

We are revising part 1207, subpart A.

Acronyms, Addresses, Agency Names, and Sections.In paragraph (a) of § 1207.1, we removed the first sentence and replaced it with sentences rewritten in Plain Language. Also, in paragraph (b) of § 1207.1, we are rewriting the paragraph in Plain Language to include ONRR's address and the OMB control number. We also are amending sections to replace “Bureau of Ocean Energy Management, Regulations, and Enforcement (BOEMRE)” with “Bureau of Ocean Energy Management (BOEM)” and “BOEMRE” with “BOEM.” In addition, we are adding “Bureau of Safety and Environmental Enforcement” to § 1207.5 so that BSEE will receive copies of all sales contracts, agreements, etc.

E. Part 1210—Forms and Reports

We are revising part 1210, subparts A, B, C, D, E, and H.

OMB-approved Form Numbers.Currently, 30 CFR 1210.10 contains a list of information collections that OMB approved prior to ONRR's separation from BOEMRE. In this rule, we are providing, under 30 CFR 1210.10, an updated information collection requests (ICR) table showing the OMB-approved form numbers for current ICRs. We are amending the OMB-approved form numbers, listed in this part, to replace “MMS” with “ONRR” as we complete our form-update process. We also are correcting § 1210.205 to label the first paragraph as “(a).” In addition, we are revising § 1210.353 in Plain Language.

F. Part 1218—Collection of Royalties, Rentals, Bonuses, and Other Monies Due the Federal Government

We are revising part 1218, subparts A, B, D, E, and H.

Acronyms, Agency Name, OMB-approved Form Numbers, and Section Numbers.We are amending sections to replace “BOEMRE” with “Bureau of Safety and Environmental Enforcement (BSEE)” and “BSEE.” We also are amending the form numbers, listed in this part, to replace “MMS” with “ONRR” as we complete our form-update process. In addition, we are correcting referenced section numbers due to reorganizing and repromulgating our regulations in chapter XII, title 30 CFR.

Acronyms, Agency names, and Definition.We are amending subparagraph (1) in the definition ofCapital recovery periodin § 1220.002 to replace “Bureau of Ocean Energy Management, Regulations, and Enforcement (BOEMRE)” with “Bureau of Ocean Energy Management (BOEM).” We also are amending subparagraph (3) in the definition ofCapital recovery periodin § 1220.002 to replace “Director” with “BOEM Director.” We also are deleting the definition ofDirectorin § 1220.002 because we will list and identify three different Directors in the Department of the Interior (DOI) who we reference in this part. In addition, we are amending sections to replace “Director” with “BOEM Director” or “Bureau of Safety and Environmental Enforcement (BSEE) Director” or “BSEE Director” or “Office of Natural Resources Revenue (ONRR) Director” or “ONRR Director.”

Acronym, Agency name, and Definition.We are amending the definition of “ONRR bond-approving officer”in § 1243.3 to replace “Associate Director for Minerals Revenue Management” with “Deputy Director for Office of Natural Resources Revenue” and “Associate Director” with “Deputy Director.” We also are amending § 1243.8 to replace “BOEMRE” with “Bureau of Ocean Energy Management.”

Subchapter B—AppealsI. Part 1290—Appeal Procedures

We are amending part 1290 by updating referenced section text to replace “subpart” with “part” due to reorganizing and repromulgating our regulations in chapter XII, title 30 CFR.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866, while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that agencies must base regulations on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

Regulatory Flexibility Act

DOI certifies that this direct final rule does not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.). This direct final rule will impact large and small entities but will not have a significant economic effect on either because this is a technical rule renumbering already approved OMB control numbers, renaming certain forms, and correcting corresponding part and position titles, agency names, and acronyms for ONRR's information collection requirements (ICRs) listed in title 30 CFR, chapter XII, regulations.

Small Business Regulatory Enforcement Fairness Act

This direct final rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This direct final rule:

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This is only a technical rule renumbering already approved OMB control numbers, renaming certain forms, and correcting corresponding part and position titles, agency names, and acronyms for ONRR's information collection requirements (ICRs) listed in title 30 CFR, chapter XII, regulations.

Unfunded Mandates Reform Act

This direct final rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. This direct final rule does not have asignificant or unique effect on State, local, or tribal governments or the private sector. We are not required to provide a statement containing the information that the Unfunded Mandates Reform Act (2 U.S.C. 1531et seq.) requires because this is a technical rule renumbering already approved OMB control numbers, renaming certain forms, and correcting corresponding part and position titles, agency names, and acronyms for ONRR's ICRs.

Takings (E.O. 12630)

Under the criteria in section 2 of Executive Order 12630, this direct final rule does not have any significant takings implications. This direct final rule applies to Outer Continental Shelf (OCS), Federal onshore, and Indian onshore leases. It does not apply to private property. This direct final rule does not require a Takings Implication Assessment.

Federalism (E.O. 13132)

Under the criteria in section 1 of Executive Order 13132, this direct final rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This is a technical rule renumbering already approved OMB control numbers, renaming certain forms, and correcting corresponding part and position titles, agency names, and acronyms for ONRR's ICRs listed in title 30 CFR, chapter XII, regulations. This direct final rule does not require a Federalism summary impact statement.

Civil Justice Reform (E.O. 12988)

This direct final rule complies With the requirements of E. O. 12988 for the reasons outlined in the following paragraphs.

a. This rule meets the criteria of section 3(a), which requires that we review all regulations to eliminate errors and ambiguity and to write them to minimize litigation.

b. This rule meets the criteria of section 3(b)(2), which requires that we write all regulations in clear language with clear legal standards.

Consultation With Indian Tribes (E.O. 13175 and Department policy)

DOI strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. Under DOI's consultation policy and the criteria in Executive Order 13175, we have evaluated this direct final rule and determined that it has no substantial direct effects on federally recognized Indian tribes. Therefore, we are not required to complete a consultation under DOI's tribal consultation policy.

Paperwork Reduction Act

This direct final rule does not contain any information collection requirements and does not require a submission to OIRA under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.).

National Environmental Policy Act

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. We are not required to provide a detailed statement under the National Environmental Policy Act of 1969 (NEPA) because this rule qualifies for categorical exclusion under 43 CFR 46.210(i) and the DOI Departmental Manual, part 516, section 15.4.D: “(i) Policies, directives, regulations, and guidelines: that are of an administrative, financial, legal, technical, or procedural nature.” We have also determined that this rule is not involved in any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA. The procedural changes resulting from these amendments have no consequences with respect to the physical environment. This rule will not alter in any material way natural resource exploration, production, or transportation.

Information Quality Act

In accordance with the Information Quality Act, DOI has issued guidance regarding the quality of information that it relies on for regulatory decisions. This guidance is available on DOI's Web site athttp://www.doi.gov/ocio/information_management/iq.cfm.

Effects on the Energy Supply (E.O. 13211)

This direct final rule is not a significant energy action under the definition in E.O. 13211, and, therefore, it does not require a Statement of Energy Effects.

For the reasons discussed in the preamble, under the authority provided by the Reorganization Plan No. 3 of 1950 (64 Stat. 1262) and Secretarial Order Nos. 3299 and 3302, ONRR amends parts 1202, 1204, 1206, 1207, 1210, 1218, 1220, 1243, and 1290 of title 30 CFR, chapter XII, subchapters A and B, as follows:

PART 1202—ROYALTIES1. The authority citation for part 1202 continues to read as follows:Authority:

§ 1202.350[Corrected]2. Correctly revise the section designation for § 201.350 to read § 1202.350§§ 1202.100, 1202.150, 1202.151, 1202.350, 1202.353[Amended]3. In the following table, amend part 1202 in the sections indicated in the left column by removing the text in the center column and adding in its place the text in the right column:AmendBy removing the reference to:And adding in its place:§ 1202.100(b)(1)Bureau of Ocean Energy Management, Regulations, and Enforcement (BOEMRE)Bureau of Safety and Environmental Enforcement (BSEE).§ 1202.100(b)(2)BOEMREBSEE.§ 1202.100(c)BOEMREBSEE.§ 1202.150(b)(1)BOEMREBSEE.§ 1202.150(b)(2)BOEMREBSEE.§ 1202.150(c)BOEMREBSEE.§ 1202.151(c)BOEMREBureau of Ocean Energy Management (BOEM).§ 1202.353(a)MMS-2014ONRR-2014.§ 1202.353(b)MMS-2014ONRR-2014.§ 1202.353(c)MMS-2014ONRR-2014.§ 1202.353(d)MMS-2014ONRR-2014.PART 1204—ALTERNATIVES FOR MARGINAL PROPERTIES4. The authority citation for part 1204 continues to read as follows:Authority:

30 U.S.C. 1701et seq.

§§ 1204.202, 1204.206, and 1204.210[Amended]5. In the following table, amend part 1204 in the sections indicated in the left column by removing the text in the center column and adding in its place the text in the right column:AmendBy removing the reference to:And adding in its place:§ 1204.202(b)(3)MMS-2014ONRR-2014.§ 1204.202(b)(4)MMS-2014ONRR-2014.§ 1204.202(b)(5)MMS-2014ONRR-2014.§ 1204.202(d)(2)MMS-2014ONRR-2014.§ 1204.202(e)(2)§ 218.54§ 1218.54.§ 1204.206 introductory text§ 204.1205(b)§ 1204.205(b).§ 1204.210 introductory textBOEMREBOEM.§ 1204.210(b)BOEMREBOEM.§ 1204.210(c) (two times)BOEMREBOEM.§ 1204.215[Amended]6. Revise § 1204.215 to read as follows:§ 1204.215Are the information collection requirements in this subpart approved by the Office of Management and Budget (OMB)?

OMB approved the information collection requirements contained in this subpart under 44 U.S.C. 3501et seq.ONRR identifies the approved OMB control number in 30 CFR 1210.10.

PART 1206—PRODUCT VALUATION7. The authority citation for part 1206 continues to read as follows:Authority:

(a) ONRR uses the information collected to determine a proper transportation allowance for the cost of transporting royalty oil from the lease to a delivery point remote from the lease. The information is required so that the lessee may obtain a benefit under the Federal Oil and Gas Royalty Management Act of 1982, 30 U.S.C. 1701et seq.The Office of Management and Budget (OMB) approved the information collection requirements contained in this part under 44 U.S.C. 3501et seq.ONRR identifies the approved OMB control number in 30 CFR 1210.10.

(b) Send comments regarding the burden estimates or any other aspect of this information collection, including suggestions for reducing burden, to the Office of Natural Resources Revenue, Attention: Rules & Regs Team, OMB Control Number 1012-0002, P.O. Box 25165, Denver, CO 80225-0165.

§§ 1207.4 and 1207.5[Amended]14. In the following table, amend part 1207 in the sections indicated in the left column by removing the text in the center column and adding in its place the text in the right column:AmendBy removing the reference to:And adding in its place:§ 1207.4(a)Bureau of Ocean Energy Management, Regulation, and Enforcement (BOEMRE)Bureau of Ocean Energy Management (BOEM).§ 1207.5BOEMREBOEM, Bureau of Safety and Environmental Enforcement (BSEE).PART 1210—FORMS AND REPORTS15. The authority citation for part 1210 continues to read as follows:Authority:

16. In § 1210.10, revise the table to read as follows:§ 1210.10What are the OMB-approved information collections?OMB Control number and short titleForm or information collected1012-0001, CFO Act of 1992, Accounts Receivable ConfirmationsNo form for the following collection:

1Lessees use Form ONRR-4393 for both Federal and Indian oil and gas leases. The form resides with ICR 1012-0005, but ONRR includes the burden hours for Indian leases in ICR 1012-0002.17. Amend § 1210.205 by revising paragraph (a) introductory text to read as follows:

(a)General.You must submit the following ONRR forms to claim a transportation or washing allowance, as applicable, on Indian coal leases:

You must submit a completed Report of Sales and Royalty Remittance (Form ONRR-2014) each month once sales or use of production occur, even though sales may be intermittent, unless ONRR otherwise authorizes. This report is due on or before the last day of the month following the month in which production was sold or used, together with the royalties due to the United States.

PART 1218—COLLECTION OF ROYALTIES, RENTALS, BONUSES, AND OTHER MONIES DUE THE FEDERAL GOVERNMENT20. The authority citation for part 1218 continues to read as follows:Authority:

EPA is approving revisions to the Wisconsin State Implementation Plan (SIP), submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 4, 2011, June 20, 2012, and September 28, 2012. The revisions modify Wisconsin's Prevention of Significant Deterioration (PSD) program to establish appropriate emission thresholds for determining which new stationary sources and modification projects become subject to Wisconsin's PSD permitting requirements for their greenhouse gas (GHG) emissions. Additionally, these revisions defer until July 21, 2014, the application of the PSD permitting requirements to biogenic carbon dioxide (CO2) emissions from bioenergy and other biogenic stationary sources in the State of Wisconsin. EPA has made the preliminary determination that these revisions are in accordance with the Clean Air Act (CAA) and EPA regulations regarding PSD permitting for GHGs and is approving Wisconsin's revisions.

DATES:

This final rule is effective on June 21, 2013.

ADDRESSES:

EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2011-0467, or EPA-R05-OAR-2012-0538. All documents in the docket are listed in thewww.regulations.govWeb site. Although listed in the index, some information is not publicly available,e.g.,Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically throughwww.regulations.govor in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Danny Marcus, Environmental Engineer, at (312) 353-8781 before visiting the Region 5 office.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. ThisSUPPLEMENTARY INFORMATIONsection is arranged as follows:

I. What is being addressed by this document?II. What comments did we receive on the proposed rule?III. What action is EPA taking?IV. Statutory and Executive Order ReviewsI. What is being addressed by this document?

On December 28, 2012, at 77 FR 76430, EPA proposed to approve into the state's Federally-approved SIP regulatory additions that Wisconsin submitted which are consistent with the “PSD and Title V Greenhouse Gas Tailoring; Final Rule,” 75 FR 31514 (June 3, 2010) (The “Tailoring Rule”), the “Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources in State Implementation Plans Final Rule,” 75 FR 82536 (December 30, 2010) (The “PSD SIP Narrowing Rule”) and the “Deferral for CO2Emissions From Bioenergy and Other Biogenic Sources Under the Prevention of Significant Deterioration (PSD) and Title V Programs; Final Rule” 76 FR 43490, July 20, 2011.

These rules establish thresholds and time frames that ensure that smaller GHG sources emitting less than these thresholds will not be subject to PSD permitting requirements for the GHGs that they emit, and defer consideration of CO2emissions from bioenergy and other biogenic sources (biogenic CO2emissions) when determining whether the modification of a stationary source would result in a net emissions increase that would trigger PSD thresholds and would require the application of Best Available Control Technology.

II. What comments did we receive on the proposed rule?

EPA provided a 30-day review and comment period. The comment period closed on January 28, 2013. EPA received one comment supporting EPA's approval of these revisions. EPA received no adverse comments.

III. What action is EPA taking?

EPA is approving Wisconsin's May 4 2011, June 20 2012, and September 28 2012, SIP submittals. Specifically, EPA is approving revisions to chapters NR 400.02 (74m); 400.03 (3) (om), and (4) (go) and (kg); 405.02 (28m); 405.07 (9) of the Wisconsin Administrative Code and Wisconsin State Statutes, Sections 285.60(3m) and 285.63(3m) into the SIP. These revisions implement the Tailoring Rule and Deferral of CO2emissions from biogenic sources.

Because Wisconsin's changes to its air quality regulations will incorporate the appropriate thresholds for GHG permitting applicability into its SIP, EPA is also amending 40 CFR 52.2572, to remove subsection (b), which is being replaced by the new rules that Wisconsin has submitted. The new rules are consistent with the Federal Tailoring Rule provisions, which limit the applicability of PSD to GHG-emitting sources below the Tailoring Rule thresholds.

IV. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submissionthat complies with the provisions of the CAA and applicable Federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register.A major rule cannot take effect until 60 days after it is published in theFederal Register.This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 22, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS1. The authority citation for part 52 continues to read as follows:Authority:

42 U.S.C. 7401et seq.

2. Section 52.2570 is amended by adding paragraph (c)(126) to read as follows:§ 52.2570Identification of plan.

(c) * * *

(126) On May 4, 2011, June 20, 2012, and September 28, 2012, the Wisconsin Department of Natural Resources submitted a request to revise Wisconsin's Prevention of Significant Deterioration (PSD) program to incorporate the “Tailoring Rule” and the Federal deferral for biogenic CO2emissions into Wisconsin's SIP.

(C) Wisconsin Administrative Code, NR 405.02 Definitions. NR 405.02(28m) “Subject to regulation under the Act”, as published in the Wisconsin Administrative Register August 2011, No. 668, effective September 1, 2011.

(D) Wisconsin Administrative Code, NR 405.07 Review of major stationary sources and major modifications—source applicability and exemptions. NR 405.07(9), as published in the Wisconsin Administrative Register August 2011, No. 668, effective September 1, 2011.

EPA is taking final action to approve three revisions to the Arizona State Implementation Plan submitted by the Arizona Department of Environmental Quality. Two of these revisions relate to an amendment to Arizona's vehicle emissions inspection program that exempts motorcycles in the Phoenix metropolitan area fromemissions testing requirements. The third revision expands the geographic area in which various air quality control measures, including the vehicle emissions inspection program but also including other control measures, apply in the Phoenix metropolitan area. EPA is approving these SIP revisions based on our conclusion that the SIP revisions meet all applicable requirements and would not interfere with reasonable further progress or attainment of any of the national ambient air quality standards. EPA is finalizing this action under the Clean Air Act obligation to take action on State submittals of revisions to state implementation plans.

DATES:

Effective Date:This rule is effective on June 21, 2013.

ADDRESSES:

EPA has established docket number EPA-R09-OAR-2011-0552 for this action. Generally, documents in the docket for this action are available electronically atwww.regulations.govand in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed atwww.regulations.gov,some information may be publicly available only at the hard copy location (e.g., copyrighted material, large maps, multi-volume reports), and some may not be publicly available in either location (e.g., Confidential Business Information). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in theFOR FURTHER INFORMATION CONTACTsection.

On November 5, 2012 (77 FR 66422), EPA proposed to approve revisions to the Arizona state implementation plan (SIP) submitted by the Arizona Department of Environmental Quality (ADEQ) that would exempt motorcycles in the Phoenix metropolitan area from testing under the Arizona motor vehicle emissions inspections and maintenance (“VEI”) program and that would expand the geographic area in which certain air pollution control programs apply within the Phoenix metropolitan area. We proposed these actions under section 110(k) of the Clean Air Act (CAA or “Act”). (The State of Arizona developed the VEI program to reduce emissions of carbon monoxide (CO), volatile organic compounds (VOC) and oxides of nitrogen (NOX) from in-use motor vehicles in the Phoenix and Tucson areas.1)

1VOC and NOXare precursors to ozone formation in the atmosphere under the influence of sunlight and meteorology.

Specifically, we proposed to approve the submittal on November 6, 2009 of “Final Arizona State Implementation Plan Revision, Exemption of Motorcycles from Vehicle Emissions Inspections and Maintenance Program Requirements in Area A” (October 2009) (“2009 VEI SIP Revision”) and the submittal on January 11, 2011 of “Final Addendum to the Arizona State Implementation Plan Revision, Exemption of Motorcycles from Vehicle Emissions Inspections and Maintenance Program Requirements in Area A, October 2009” (December 2010) (“2011 VEI SIP Addendum”).

As described in our November 5, 2012 proposed rule, the 2009 VEI SIP Revision submittal includes a non-regulatory portion that provides analyses of emission impacts due to the motorcycle exemption, a demonstration that the exemption would not interfere with attainment or maintenance of the national ambient air quality standards (NAAQS or “standards”), and a contingency measure establishing a binding commitment on ADEQ to request Legislative action to reinstate emissions testing for motorcycles in the Phoenix area should the Phoenix area experience a violation of the carbon monoxide NAAQS. The 2009 VEI SIP Revision also includes a regulatory portion comprised by House Bill (HB) 2280, enacted by Arizona in 2008 to take effect upon EPA approval. HB 2280 amends the Arizona Revised Statutes (ARS) section 49-542 (“Emissions inspection program; powers and duties of director; administration; periodic inspection; minimum standards and rules; exceptions; definition”) by exempting motorcycles in Area A (i.e., the Phoenix area) from emissions testing under the VEI program.2 3The 2011 VEI SIP Revision includes additional information regarding the impacts of the motorcycle exemption on attainment of the 2008 8-hour ozone NAAQS and the 1987 PM10NAAQS and includes a substitute measure to offset the VOC emission reductions foregone by the exemption of motorcycles from the VEI emissions testing requirement.

2The changes to ARS Section 49-542 are self-implementing, which means that they become effective upon EPA approval as a revision to the Arizona SIP. See page 4 of the 2009 VEI SIP Revision.

3On January 28, 2013, at EPA's request, ADEQ supplemented appendix A of the 2009 VEI SIP Revision with a certified copy of the codified version of ARS section 49-542, along with two House Bills that extended the conditional enactment date set for July 2010 in House Bill 2280 to July 2012, and then to July 2014. We are taking final action to approve this certified copy of ARS 49-542 in today's action.

With respect to the SIP revision that would expand the geographic area in which certain air pollution control programs apply within the Phoenix metropolitan area, we noted in our November 5, 2012 proposed rule that the relevant amended statutory definition of “Area A” was included in ADEQ's May 25, 2012 submittal of theMAG 2012 Five Percent Plan for PM-10 for the Maricopa County Nonattainment Area (May 2012)(“2012 Phoenix Area PM-10 Five Percent Plan”). Specifically, ADEQ included ARS 49-541(1) (“Definitions”) as amended by the Arizona Legislature in 2001 as part of the submittal of the 2012 Phoenix Area PM-10 Five Percent Plan. ARS 49-541(1) establishes the boundaries of Area A.4

4ADEQ included ARS 49-541(1) in exhibit 1 in Appendix C to the 2012 Phoenix Area PM-10 Five Percent Plan. With respect to ADEQ's May 25, 2012 SIP revision submittal of the 2012 Phoenix Area PM-10 Five Percent Plan, EPA is taking action today only on the amended statutory provision that expands the boundaries of Area A [i.e., amended ARS 49-541(1)]. EPA will take action on the rest of the 2012 Phoenix Area PM-10 Five Percent Plan in one or more future rulemakings.

As explained in our proposed rule, Area A, as last approved in 2003 (68 FR 2912 (January 22, 2003)), includes all of the metropolitan Phoenix carbon monoxide and 1-hour ozone nonattainment areas plus additional areas in Maricopa County to the north, east, and west, as well as a small portion of Yavapai County and the western portions of Pinal County. “Area A” is also used by the State of Arizona to identify the applicable area for implementation of a number of air pollution control measures, including but not limited to the VEI, cleaner burning gasoline (CBG), and “stage II” vapor recovery programs. The amended “Area A” definition, included with the 2012 Phoenix Area PM-10 Five Percent Plan, extends Area A beyond the boundaries approved by EPA in 2003 to add portions of Maricopa County west of Goodyear and Peoria and a small piece of land on the north side of Lake Pleasant in Yavapai County.

As discussed in more detail on pages 66424-66428 of the November 5, 2012 proposed rule, we proposed to approvethe exemption for Phoenix-area motorcycles from the emissions testing requirements under the VEI program because:

• With respect to all three SIP revisions, ADEQ has met the procedural (i.e. public process) requirements for SIP revisions under CAA section 110(l) and 40 CFR part 51, subpart F;

• With the emissions testing exemption for motorcycles in the Phoenix metropolitan area, the Arizona VEI would continue to meet Federal minimum requirements for vehicle inspection and maintenance (I/M) programs;

• The VEI program, as amended to exempt motorcycles from the emissions testing requirement, would continue to meet or exceed the alternate low enhanced I/M performance standard in the Phoenix area as required under 40 CFR 51.351 and 51.905(a)(1);

• The motorcycle exemption would not interfere with attainment or maintenance of any of the NAAQS and would thereby comply with section 110(l) of the CAA because the potential incremental increase in emissions of CO, VOC and PM-10 due to foregone motorcycle emissions testing and maintenance would be more than offset by the emissions impact of expanding the boundaries of “Area A”5because “Area A” defines the area of applicability for various air pollution control measures, such as the VEI program, the CBG program, the “stage II” vapor recovery program, and various PM-10 control measures, and expanding the boundaries of “Area A” thus extends these programs to areas not otherwise covered for the purposes of the Arizona SIP; and

5For example, the proposed rule, at page 66427, compares the estimated 1.3 metric tons per day of VOC emissions reductions from expansion of Area A boundaries with the estimated 0.1 metric ton per day of VOC emissions increases from foregone emissions testing under the VEI program for Phoenix area motorcycles.

• The 2009 VEI SIP Revision includes a commitment by ADEQ, i.e., to request Legislative action to reinstate emissions testing for motorcycles in the Phoenix area should the area experience a violation of the CO standards, that we find complies with the contingency measure requirements under section 175A(d) of the CAA with respect to the Phoenix area, which is a “maintenance” area for the CO standard.

For background information about the EPA's regulations governing motor vehicle inspection and maintenance programs (I/M), the development and evolution of Arizona's VEI program, EPA's actions in connection with that program, as well as additional information concerning the State's public process for adopting these SIP revisions, and our rationale for proposing approval of the three subject SIP revisions, please see our November 5, 2012 proposed rule.

II. Response to Comments

Our November 5, 2012 proposed rule provided a 30-day public comment period. We received comments from 15 commenters on our proposed rule during the public comment period. All of the commenters except for two expressed their support for EPA's proposed action. In the following paragraphs, we summarize the comments objecting to our proposed action and provide our responses.

Comment #1:The commenter agrees with the proposal to exempt motorcycles from emissions testing, but objects to the expansion of Area A because it expands the use of special gasoline blends (summer and winter) that the commenter believes do nothing for the environment and contribute to fuel shortages and excessive retail fuel costs. The commenter also suggests that the emissions testing exemption for newer model year vehicles be increased from 5 to 10 years based on engine technology improvements.

Response #1:First of all, EPA disagrees with the contention that the special gasoline blends in effect in the Phoenix metropolitan area, and referred to as the “cleaner burning gasoline” (CBG) program, do nothing for the environment. To the contrary, EPA has approved a number of Phoenix area air quality plans that rely on the continuation of the CBG program to attain and maintain the NAAQS. For instance, in theCarbon Monoxide Redesignation Request and Maintenance Plan for the Maricopa County Nonattainment Area(May 2003), which was approved by EPA at 70 FR 11553 (March 9, 2005), the Maricopa Association of Governments (MAG) credits CBG with providing over 20% of the CO emissions reductions relied upon to demonstrate maintenance of the CO standard through the first ten years beyond redesignation.6More recently, in theEight-Hour Ozone Plan for the Maricopa Nonattainment Area(June 2007), approved by EPA at 77 FR 35285 (June 13, 2012), MAG credits CBG with providing 3.5% of the NOXreductions that the plan relies upon to demonstrate attainment of the 1997 8-hour ozone standard in the Phoenix-Mesa area.7

Second, we note that the commenter does not challenge EPA's conclusion that the expansion of Area A meets all applicable CAA requirements but rather contends that the extension of CBG to a larger area would increase retail fuel costs and lead to fuel shortages. However, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the minimum criteria set in the Clean Air Act or any applicable EPA regulations. Thus, considerations such as whether a State rule may be economically or technologically challenging cannot form the basis for EPA disapproval of a rule submitted by a state as part of a SIP [seeUnion Electric Companyv.EPA;427 U.S. 246, 265 (1976)]. Also, EPA disapproval of ADEQ's submittal of the statutory provision expanding Area A would not prevent the implementation of CBG in the larger area because the expanded definition of Area A and related CBG requirements would still apply in the larger area, and would still be enforceable, under State law, regardless of EPA's action to approve or disapprove the amended definition as a revision to the Arizona SIP.

Lastly, with respect to the suggestion that the emissions testing exemption for newer model year vehicles should be increased from 5 to 10 years, any changes to the exemption for motor vehicle emissions testing would first require a change in Arizona law. Thus, the commenter should direct this suggestion to State officials in the first instance. If such a statutory change were to be adopted, ADEQ would need to adopt and submit the change as a revision to the Arizona SIP, including documentation showing that the revision meets all relevant CAA and EPA requirements—including a demonstration that the change would not interfere with reasonable further progress or attainment of the NAAQS under section 110(l) of the Act. Upon receipt of a complete SIP revision, EPA would then consider approval or disapproval in the context of notice-and-comment rulemaking.

Comment #2:The commenter objects to EPA's proposed approval of the exemption for motorcycles because motorcycle-related emissions contribute to the overall problem of poor air quality in the Phoenix metropolitan area and should not be ignored even though it may be small in comparison to the emissions generated by cars.

Response #2:In support of the contention that motorcycle emissions do contribute to overall air quality problems in the Phoenix metropolitan area, the commenter presents an estimate of total emissions from motorcycles in the Phoenix area that, as corrected for a computational error and adjusted for unit conversions, are not inconsistent with the corresponding estimates of motorcycle emissions prepared by MAG in theEight-Hour Ozone Redesignation Request and Maintenance Plan for the Maricopa Nonattainment Area(February 2009).8However, we did not propose to approve the VEI exemption for motorcycles based on the relatively low contribution of motorcycle emissions to overall pollutant emissions in the Phoenix metropolitan area. Rather, we based our proposed approval on our conclusion that the VEI program, as amended to include the motorcycle exemption, would continue to meet Federal I/M requirements and that any increase in emissions due to the exemption would be offset by the reduction in emissions due to the extension of various control measures to a larger geographic area by virtue of the amended statutory definition of “Area A.”

8InEight-Hour Ozone Redesignation Request and Maintenance Plan for the Maricopa Nonattainment Area(February 2009) (see page 109 of the Appendix A, Exhibit 1 (“2005 Ozone Periodic Emission Inventory”), MAG estimates that motorcycles in year 2005 emitted approximately 660 tons per year (tpy), 200 tpy, and 2,620 tpy of VOC, NOX,and CO, respectively, within the Phoenix-Mesa 8-hour ozone nonattainment area. The corresponding estimates prepared by the commenter, as corrected for an error in computation (i.e., the commenter's calculated estimate of CO per bike should have been 33,817 grams (per year) instead of 3,137 grams (per year) based on 7 grams per kilogram and 4,831 kilometers driven per year per bike) and converted to tons per year, are approximately 360 tpy for VOC (and for VOC+NOX) and 2,720 tpy for CO.

More specifically, in connection with the emissions impact analysis submitted by ADEQ, we agreed with its focus on the incremental change due to foregone emissions testing and maintenance of motorcycles under the VEI program rather than on total motorcycle-related emissions. Next, we found ADEQ's emissions estimates for the incremental increase to be reasonable. Converted to tons per year, ADEQ's estimates for the incremental increase amounts to approximately 20 tpy for VOC and 100 tpy for CO (see the column labeled “I/M benefit from motorcycle testing and repair” in table 2 of EPA's November 5, 2012 proposed rule). As to this incremental increase in VOC and CO emissions, we concluded that the incremental increase in emissions due to foregone emissions testing and maintenance would not interfere with attainment or maintenance of any of the NAAQS given the emissions benefits associated with the expansion of Area A and the related extension of various air quality control measures to the larger area, including the VEI program, the CBG program, the vapor recovery program, and various PM-10 control measures, given that the geographic applicability for all of these programs is defined by “Area A.” See page 66426-66428 of EPA's November 5, 2012 proposed rule.

III. EPA's Final Action

Under section 110(k) of the CAA, and for the reasons set forth in our November 5, 2012 proposed rule and summarized herein, EPA is taking final action to approve the revisions to the Arizona SIP submitted by ADEQ on November 6, 2009 and January 11, 2011 concerning the exemption of motorcycles from the emissions testing requirements under the Arizona VEI program in the Phoenix area, because we find that the revisions meet all applicable requirements, and together with the expansion of the geographic area to which the VEI and other air pollution control measures apply, would not interfere with reasonable further progress or attainment of any of the national ambient air quality standards. In connection with our approval of the State's exemption of motorcycles from the VEI emissions testing requirements, we are approving an amended statute, Arizona Revised Statutes (ARS) section 49-542, that codifies this exemption in State law.9

9Final approval of the current version of ARS 49-542 exempting motorcycles from VEI emissions testing requirements supersedes the previous versions of ARS 49-542 approved by EPA and made a part of the applicable Arizona SIP. The most recent prior approval by EPA of ARS 49-542 was published at 72 FR 15046 (March 30, 2007).

EPA is also approving the revised statutory provision [amended Arizona Revised Statutes (ARS) section 49-541(1)], submitted by ADEQ on May 25, 2012,10that expands the boundaries of Area A, i.e., the area in which the various air pollution control measures (including the VEI, and cleaner burning gasoline and stage II vapor recovery programs) in the Phoenix area apply.

10Final approval of the amendment to ARS 49-541(1) expanding the boundaries of “Area A” to those promulgated by the Arizona Legislature in 2001 supersedes the previous versions of ARS 49-541(1) approved by EPA and made a part of the applicable Arizona SIP. The most recent prior approvals by EPA of the definition of “Area A” in ARS 49-541(1) were published at 68 FR 2912 (January 22, 2003) and 69 FR 10161 (March 4, 2004). The definition of the boundaries of “Area A” in ARS 49-541(1) was the same in both the 2003 and 2004 final approval actions and reflect the boundaries promulgated by the Arizona Legislature in 1999. Approval of the amended statutory definition of “Area A” in today's final action expands the geographic applicability of the VEI program, the CBG program, the Stage II vapor recovery program and any other Arizona SIP control measure that relies on the definition of “Area A” in ARS 49-541(1) under the Arizona SIP.

IV. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 22, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (Seesection 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations are amended as follows:

PART 52—[AMENDED]1. The authority citation for part 52 continues to read as follows:Authority:

42 U.S.C. 7401et seq.

Subpart D—Arizona2. Section 52.120 is amended by adding paragraphs (c)(155), (c)(156), and (c)(157) to read as follows:§ 52.120Identification of plan.

(c) * * *

(155) The following plan was submitted on November 6, 2009 by the Governor's designee.

(i) Incorporation by reference.

(A) Arizona Department of Environmental Quality.

(1) Affidavit by Efrem K. Sepulveda, Law Librarian, Arizona State Library, Archives and Public Records, certifying authenticity of reproduction of A.R.S. § 49-542 (2008 edition) plus title page to pocket part of Title 49 (2008 edition), signed January 11, 2013.

(1) Final Arizona State Implementation Plan Revision, Exemption of Motorcycles from Vehicle Emissions Inspections and Maintenance Program Requirements in Area A (October 2009), adopted by the Arizona Department of Environmental Quality on November 6, 2009, excluding appendices A and C.

(156) The following plan was submitted on January 11, 2011 by the Governor's designee.

(i) [Reserved]

(ii) Additional materials.

(A) Arizona Department of Environmental Quality.

(1) Final Addendum to the Arizona State Implementation Plan Revision, Exemption of Motorcycles from Vehicle Emissions Inspections and Maintenance Program Requirements in Area A, October 2009 (December 2010), adopted by the Arizona Department of Environmental Quality on January 11, 2011.

(157) The following plan was submitted on May 25, 2012 by the Governor's designee.

This regulation establishes tolerances for residues of 1-naphthaleneacetic acid in or on avocado; fruit, pome, group 11-10; mango; sapote, mamey; and rambutan. This regulation additionally deletes certain tolerances, identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective May 22, 2013. Objections and requests for hearings must be received on or before July 22, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of theSUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0203, is available athttp://www.regulations.govor at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available athttp://www.epa.gov/dockets.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0203 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 22, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0203, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

•Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.II. Summary of Petitioned-For Tolerance

In theFederal Registerof May 2, 2012 (77 FR 25954) (FRL-9346-1), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2E7991) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.155 be amended by establishing tolerances for residues of the plant growth regulator 1-naphthaleneacetic acid and its conjugates in or on rambutan at 3 parts per million (ppm); avocado, mango, and sapote, mamey at 0.05 ppm; and fruit, pome, group 11-10 at 0.15 ppm. The petition additionally requested to amend the tolerances in 40 CFR 180.155 by removing the tolerance for fruit, pome, group 11 at 0.15 ppm, as it will be superseded by the tolerance on fruit, pome, group 11-10 at 0.15 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by Amvac Chemical Corporation, the registrant, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance on rambutan from 3.0 ppm to 2.0 ppm. The Agency has also revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reason for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in that section, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for 1-naphthaleneacetic acid, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with 1-naphthaleneacetic acid follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Based on structural activity relationship and metabolism data, all forms of 1-naphthaleneacetic acid, its salts, ester, and acetamide which are collectively referred to as naphthalene acetates (NAA), are expected to exhibit similar toxicological effects. In selecting endpoints of toxicity for risk assessment to exposures to the various NAA forms, the most conservative endpoint was selected from the studies that showed the lowest NOAELs for assessing a particular exposure. In addition, all forms degrade to the acid fairly quickly in the field and in biological systems.Therefore, EPA has concluded that required toxicity testing on any form should serve for all members of this group of chemicals.

Repeated oral exposures to NAA in rats and dogs resulted in decreased body weights, and body weight gains accompanied by decreased food consumption. The major target organs from subchronic and chronic oral exposures were the liver, stomach, and lung. Repeated oral exposures also resulted in decreased hematocrit and hemoglobin, along with reduced red blood cell count in rats and dogs and hypocellularity of the bone marrow in dogs.

There was no developmental toxicity at the highest dose of NAA (the acid) tested in the rat or in the rabbit (orally gavaged), but developmental toxicity (decreased fetal weight and minor skeletal changes) were seen in rats orally gavaged with the sodium salt. Reproductive effects of NAA sodium salts were limited to reduced litter survival and pup weight throughout lactation in both generations of offspring in a 2-generation reproduction study.

NAA and its acetamide and the ethyl ester were tested for mutagenic effects in a gene mutation bacterial assay, mouse lymphoma assay, and mouse erythrocyte micronucleus assay, mouse lymphoma assay, and mouse erythrocyte micronucleus assay and were not found to be mutagenic. Additionally, NAA was tested for mitotic gene conversion and dominant lethality in rats and found to be negative. In a published carcinogenicity study of NAA acetamide in mice and a guideline chronic/oncogenicity study of NAA sodium salt in rats and mice, NAA compounds were not carcinogenic in mice or rats.

Specific information on the studies received and the nature of the adverse effects caused by NAA as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document: “Naphthalene Acetates Human Health Risk Assessment for a Proposed Use on Avocado, Mango, Mamey Sapote, Rambutan, and Updating Crop Group Fruit, Pome, Group 11-10.” at pages 42-50 in docket ID number EPA-HQ-OPP-2012-0203.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors (U/SF) are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for NAA used for human risk assessment is shown in Table 1 of this unit.

Table 1—Summary of Toxicological Doses and Endpoints for NAA for Use in Human Health Risk AssessmentExposure/scenarioPoint of departure and uncertainty/safety factorsRfD, PAD, LOC for risk

assessment

Study and toxicological effectsAcute dietary (General population including infants and children and females 13-49 years of age)An acute RfD for the general population or any population subgroups was not selected because no effect attributable to a single exposure was observed in animal studies.Chronic dietary (All populations)NOAEL = 15 mg/kg/day

UFA= 10x

UFH= 10x

FQPA SF = 1x

Chronic RfD = 0.15 mg/kg/day

cPAD = 0.15 mg/kg/day

Chronic Toxicity—Dog LOAEL = 75 mg/kg/day based on stomach lesions in 75% of the males and by slight sinusoidal histiocytosis in the liver of 50% of the males.Dermal short-term (1 to 30 days)Dermal study

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to NAA, EPA considered exposure under the petitioned-for tolerances as well as all existing NAA tolerances in 40 CFR 180.155. EPA assessed dietary exposures from NAA in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for NAA; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues for all commodities. In addition, DEEM version 7.81 default processing factors were used, when appropriate.

iii.Cancer.Based on the data summarized in Unit III.A., EPA has concluded that NAA does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv.Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for NAA. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water.The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for NAA in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of NAA. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of NAA for chronic exposures for non-cancer assessments are estimated to be 2.99 parts per billion (ppb) for surface water and 0.0226 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 3.0 ppb was used to assess the contribution to drinking water.

3.From non-dietary exposure.The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). NAA is currently registered for root dip and sprout inhibition applications to ornamentals, which could result in residential exposures. There is a potential for short-term dermal and inhalation exposures to residential handlers, resulting from loading and applying NAA. There are no residential uses for NAA that result in exposure to children via incidental oral activities. The rooting compounds are applied by holding the plant and dipping the roots into solution. Very little exposure is expected from this use. Sprout inhibitors are applied by spray or paint brush/roller after pruning trees, or by spraying near the base of the tree after pruning root suckers. There is very little potential for postapplication exposure to NAA for adults or children based on the residential use pattern; therefore, residential postapplication exposure is not expected, nor is intermediate- or long-term exposure scenarios based on the intermittent nature of applications by homeowners.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4.Cumulative effects from substances with a common mechanism of toxicity.Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found NAA to share a common mechanism of toxicity with any other substances, and NAA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that NAA does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.There is low concern and no residual uncertainty for pre- and/or postnatal toxicity resulting from exposure to the NAA group of chemicals. The available data provided no indication of increased quantitative or qualitative susceptibility of rats or rabbits toin uteroexposure to NAA or to prenatal and postnatal exposure in rat reproduction studies. In the developmental toxicity study conducted with NAA sodium salt in rats, fetal toxicity (mainly decreased fetal weights and minor skeletal changes) was observed at a dose lower than the maternally toxic dose.

3.Conclusion.EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF was reduced to 1X for the oral and dermal routes of exposure and retained at 10X for the inhalation route of exposure. That decision is based on the following findings:

i. The toxicity database for NAA is not complete. EPA concluded that a 28-day inhalation toxicity study is required for NAA, based on a weight-of-evidence approach. A 10X SF was retained for the inhalation route of exposure due to the lack of the required 28-day inhalation study and given that the endpoint for subchronic inhalation is based on a developmental study (NOAEL = 50 mg/kg/day) that noted decreased body weight gains during gestation.

Additionally, recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing(OCSPP Guideline 870.7800) for pesticide registration. While an immunotoxicity study is not available for NAA, the toxicology database does not show any evidence of treatment-related effects on the immune system and the overall weight-of-evidence suggests that this chemical does not directly target the immune system. Consequently, the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently used for overall risk assessment, and therefore, an additional safety factor is not needed to account for lack of this study.

Acute and subchronic neurotoxicity studies are also required as a part of new data requirements in 40 CFR part 158; however, EPA has waived the requirement for these studies at the present time. This decision is based on: (1) The lack of neurotoxicity and neuropathology in the available toxicology studies for NAA; and (2) liver, stomach, and lung were identified as the target organs, with dogs being the most sensitive species. Therefore, neurotoxicity studies conducted in rats would not provide a more sensitive endpoint for risk assessment, and studies would be unlikely to yield PODs lower than the current PODs used for overall risk assessment.

ii. There is no indication that NAA is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that NAA results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In the developmental toxicity study conducted with NAA sodium salt in rats, fetal toxicity was observed at a dose lower than the maternally toxic dose. However, there were clear NOAELs in this developmental study and the PODs used in the chronic dietary assessment (15 mg/kg/day) are protective of the fetal effects observed in the study.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to NAA in drinking water. Based on the discussion in Unit III.C.3., regarding limited residential use patterns, exposure to residential handlers is very low and EPA does not anticipate postapplication exposure to children or incidental exposures to toddlers resulting from use of NAA in residential settings. These assessments will not underestimate the exposure and risks posed by NAA.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, NAA is not expected to pose an acute risk.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to NAA from food and water will utilize 2.0% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of NAA is not expected.

3.Short-term risk.Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though there is potential for short-term dermal and inhalation exposures to adult handlers resulting from residential applications of NAA to ornamentals, aggregate risk was not estimated for NAA because the toxicity endpoints selected for the chronic dietary route of exposure and those selected for inhalation and dermal routes of exposure are not based on common effects i.e., the chronic dietary endpoint is based on systemic effects and the dermal and inhalation endpoints are based on decreased body weight gain. Exposure pathways and routes are only aggregated when they share a common toxic effect.

4.Intermediate-term risk.Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, NAA is not expected to pose an intermediate-term risk.

5.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, NAA is not expected to pose a cancer risk to humans.

6.Determination of safety.Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to NAA residues.

IV. Other ConsiderationsA. Analytical Enforcement Methodology

An adequate enforcement method, a high performance liquid chromatography (HPLC) method using fluorescence detection (Method NAA-AM-001) and a similar method (Method NAA-AM-002), is available to enforce the tolerance expression for NAA in plant commodities.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for NAA.

C. Revisions to Petitioned-For Tolerances

Based on the data supporting the petition, EPA revised the proposed tolerance on rambutan from 3.0 ppm to2.0 ppm. The Agency revised this tolerance level based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures.

Finally, the Agency has revised the tolerance expression to clarify: (1) That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of NAA not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

V. Conclusion

Therefore, tolerances are established for residues of NAA, 1-naphthaleneacetic acid, in or on avocado at 0.05 ppm; fruit, pome, group 11-10 at 0.15 ppm; sapote, mamey at 0.05 ppm; mango at 0.05 ppm; and rambutan at 2.0 ppm. This regulation additionally removes the tolerance in or on fruit, pome, group 11 at 0.15 ppm and the time-limited tolerance in or on avocado at 0.05 ppm.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

(a)General.Tolerances are established for the residues of 1-naphthaleneacetic acid, including its metabolites and degradates in or on the commodities in the following table. Compliance with the tolerance levels specified is to be determined by measuring only 1-naphthaleneacetic acid and its conjugates, calculated as the Stoichiometric equivalent of 1-naphthaleneacetic acid, in or on the commodity.

CommodityParts per

million

Avocado0.05Cherry, sweet0.1Fruit, pome, group 11-100.15Mango0.05Olive0.7Orange0.1Pineapple10.05Potato0.01Rambutan2.0Sapote, mamey0.05Tangerine0.11There are no U.S. registrations since 1988.

This interim final rule with comment period sets the payment rates for covered services furnished to individuals enrolled in the Pre-Existing Condition Insurance Plan (PCIP) program administered directly by HHS beginning with covered services furnished on June 15, 2013. This interimfinal rule also prohibits facilities and providers who, with respect to dates of service beginning on June 15, 2013, accept payment for most covered services furnished to an enrollee in the federally-administered PCIP from charging the enrollee an amount greater than the enrollee's out-of-pocket cost for the covered service as calculated by the plan. The PCIP program was established under Section 1101 of Title I of the Patient Protection and Affordable Care Act (Affordable Care Act).

DATES:

Effective date:This interim final regulation is effective on June 15, 2013.

Comment date:To be assured consideration, written comments must be received at one of the addresses provided below, no later than 5 p.m. on July 22, 2013. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

ADDRESSES:

In commenting, please refer to file code CMS-9995-IFC3. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed).

1.Electronically.You may submit electronic comments on this regulation tohttp://www.regulations.gov.Follow the instructions under the “More Search Options” tab.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-4492 in advance to schedule your arrival with one of our staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

Inspection of Public Comments:All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:http://regulations.gov.Follow the search instructions on that Web site to view public comments.

Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

The Patient Protection and Affordable Care Act, (Pub. L. 111-148) was enacted on March 23, 2010; the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), (Pub. L. 111-152) was enacted on March 30, 2010 (collectively, “Affordable Care Act”). Section 1101 of the Affordable Care Act directs the Secretary of Health and Human Services (HHS) to establish, either directly or through contracts with states or nonprofit private entities, a temporary high risk health insurance pool program to provide access to affordable health insurance coverage to eligible uninsured individuals with pre-existing conditions. A number of states elected to contract with HHS to establish and administer a high risk pool using PCIP funds. HHS directly established and administers a high risk pool in the remaining states and the District of Columbia. (Hereafter, we generally refer to this program as the Pre-Existing Condition Insurance Plan program, or the PCIP program. We refer to the PCIP program administered by HHS as the “federally-administered PCIP” or the “Plan” and a PCIP program administered by a state or its designated entity as a “state-based PCIP.”) The PCIP program is intended to provide health insurance coverage to eligible uninsured individuals with pre-existing conditions until 2014. Beginning in 2014, most health insurance issuers will be required to offer coverage to all individuals, regardless of pre-existing conditions, pursuant to section 2704 of the Public Health Service Act. Eligible individuals will be able to obtain health insurance coverage either by enrolling in a qualified health plan offered through the new Health Insurance Exchanges (also called Marketplaces) established under section 1311 or 1321 of the Affordable Care Act, or by enrolling in health insurance coverage offered in the individual or group market outside of the Exchanges.

As a temporary bridge to the provisions that go into effect beginning in 2014, the PCIP program was designed to provide coverage to eligible individuals who have been locked out of the insurance market due to their health status. Since enrollment began in July 2010, the PCIP program has experienced significant and sustained growth, enrolling more than 135,000 otherwise uninsured individuals with pre-existing conditions. Many PCIP enrollees have serious health conditions that require immediate and ongoing medical treatment including severe or life threatening conditions such as cancer. In 2012, the average annual claims cost paid per enrollee was $32,108. This cost per enrollee exceeds even that of state high risk pools that predate the Affordable Care Act for several reasons. Like other high risk pools, PCIP enrollees are limited to people that were previously considered uninsurable due to high expected claims cost. In contrast to many state high risk pools, PCIP enrollees also do notexperience any waiting periods or pre-existing condition exclusions upon enrollment in the program.

The combined effect of the number of individuals enrolled in the program, particularly very sick individuals, their high utilization of covered services, and the statutory limitations on enrollee cost-sharing (which limits the maximum amount an enrollee pays out-of-pocket for covered services to $6,250 in 2013) has led to a situation where the overall cost of the PCIP program is higher than originally projected. While the actuarial estimates that HHS relies on to manage the program fluctuate as new claims data is received and processed, given the current enrollment projections and the current rate of claims payment, the aggregate amount needed for the payment of the expenses of the PCIP program is estimated to exceed the amount of remaining funding appropriated by Congress to pay for such expenses until the statutory end to the program in 2014, unless we implement the policy changes being announced in this interim final rule.

We have already taken measures to contain costs, with the intent of sustaining the program until 2014. In May of 2012, the federally-administered PCIP ceased paying referral fees to agents and brokers in connection with enrolled individuals they had referred to the program and began requiring that applications for enrollment include documentation showing that the individual had been denied health insurance coverage due to the existence of a pre-existing condition. On August 1, 2012, the federally-administered PCIP switched provider networks, reducing both its negotiated and out-of-network payment rates to providers. This network change was followed by a targeted effort to negotiate additional discounts from in-network inpatient facilities that were treating a large number of PCIP enrollees. Additionally in 2012, the federally-administered PCIP limited the specialty drug benefit such that the plan would only cover specialty drugs dispensed by in-network pharmacies.

Beginning January 1, 2013, the federally-administered PCIP implemented additional cost containment measures, including—(1) The elimination of two of three former plan options in favor of a single plan option; (2) an increase in the maximum out-of-pocket limit from $4,000 to $6,250 for in-network services; and (3) an increase in coinsurance, once the deductible has been met, from 20 percent to 30 percent of the plan allowance for in-network covered services. Furthermore, on February 15, 2013, the federally-administered PCIP suspended its acceptance of new enrollment applications until further notice.

State-based PCIPs suspended their acceptance of new enrollment applications received after March 2, 2013. Additionally, a number of state-based PCIPs have taken measures to constrain costs in their programs, for example, by renegotiating their facility and physician reimbursement rates or by setting their payment rates at levels similar to the rates paid by Medicare. Lastly, in May 2013 HHS began negotiations with state-based PCIPs on a final program contract, with a period of performance running from June 1, 2013 through December 31, 2013. The contract HHS will offer to state-based PCIPs will be a cost reimbursement contract up to, but not exceeding, the funding obligated in the contract.

Based on estimates, HHS believes it is prudent and necessary to make additional adjustments in the federally-administered PCIP with respect to payment rates for covered services in order to ensure that there is sufficient funding available to provide coverage to currently enrolled individuals until the program ends in 2014.

II. Provisions of the Interim Final Rule

This interim final rule specifies that we are using our authority under section 1101(g)(2) of the Affordable Care Act to set the payment rates for covered services in the federally-administered PCIP for dates of service beginning on June 15, 2013. As explained below, with the exception of covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits, covered services furnished to enrollees in the federally-administered PCIP program will be paid at—(1) 100 percent of Medicare payment rates, or (2) where Medicare payment rates cannot be implemented by the federally-administered PCIP, 50 percent of billed charges or a rate generated pricing methodology using a relative value scale which is generally based on the difficulty, time, work, risk and resources of the service. (Hereafter, we generally refer to this pricing methodology as “relative value scale” pricing.) These rates will become the new plan allowances for the covered services, with the Plan being responsible for reimbursing the facility or a provider for a portion and the enrollee being responsible for reimbursing the facility or provider for the remainder, as calculated by the Plan using the current cost sharing rules described in the Plan brochure.

Furthermore, to protect enrollees in the federally-administered PCIP from having to shoulder potentially significant costs that could be shifted to them as a result of this new payment policy, we are also adopting a policy that prohibits any facility or provider who, with respect to dates of service beginning on June 15, 2013, accepts payment for a covered service provided to an enrollee in the federally-administered PCIP (excepting only the four benefit categories discussed below) from charging the enrollee an amount greater than the enrollee's out-of-pocket cost for the covered service as calculated by the Plan based on the plan allowance for the covered service. In other words, as a condition of accepting payment for most covered services, facilities and providers will be prohibited from “balance billing” enrollees in the federally-administered PCIP for the difference between the plan allowance for those covered services and the charge for the covered service that they might otherwise bill to a patient who is not a federally-administered PCIP enrollee.

Presented below is a discussion of the specific regulatory provisions set forth in this interim final rule.

A. Insufficient Funds (§ 152.35(c))

Section 1101(g)(2) of the Affordable Care Act states that “[i]f the Secretary estimates for any fiscal year that the aggregate amounts available for the payment of the expenses of the high risk pool will be less than the actual amount of such expenses, the Secretary shall make such adjustments as are necessary to eliminate such deficit.” We have codified this provision at 45 CFR 152.35(b).

Since enrollment began in July 2010, the PCIP program has experienced significant and sustained growth, providing affordable health care insurance to more than 135,000 of the sickest and most vulnerable uninsured individuals with pre-existing conditions. As a result, claims paid by the PCIP program are, on average, 2.5 times higher than claims paid by state high risk pools that predate the PCIP program. Based on enrollment and claims data, current HHS estimates indicate that the aggregate amount needed to pay for PCIP program expenses may be greater than the remaining funding appropriated by Congress to pay for such expenses until coverage under the program ends in 2014. Thus, to ensure that there is sufficient funding to pay for the expenses of the PCIP program until 2014, as directed by the statute, we are adding a new § 152.35(c) to ourregulations. This new section states that with the exception of covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits, the payment rates for covered services in the federally-administered PCIP with dates of service beginning June 15, 2013 will be paid at—(1) 100 percent of Medicare payment rates; or (2) where Medicare payment rates cannot be implemented by the federally-administered PCIP, 50 percent of billed charges or a rate using relative value scale pricing methodology. For purposes of implementing this interim final rule, we presume that (for covered services paid at 50 percent of billed charges) a facility or provider's billed charge will be reasonable. Such charges are subject to review. The benefit and premium provisions codified at 45 CFR part 152 Subpart D will not change. In addition, as the new payment rates will become the new plan allowances for the covered services, we note that the Plan will be responsible for reimbursing the facility or a provider for a portion of these rates, and the enrollee will be responsible for reimbursing the facility or provider for the remainder, as calculated by the Plan using the current cost sharing rules described in the Plan brochure.

HHS chose to index the new payment rates that will apply to most covered services to the Medicare payment rate because Medicare rates are widely accepted, familiar, and publicly available. Since Medicare payment rates are well known by facilities and providers, we believe using a rate indexed to Medicare best informs them of what the payment rate for most covered services will be. Based on enrollment and claims data, current HHS estimates indicate that implementing a payment rate that is 100% percent of Medicare will allow us to ensure that there is sufficient funding to pay for the claims and administrative expenses of the PCIP program until coverage under the program ends in 2014.

Since the federally-administered PCIP utilizes a third party administrator to administer the Plan, there are a few instances where Medicare rates cannot serve as the basis for indexing the new Plan rates. The payment rate for these covered services will be 50 percent of billed charges or calculated using a relative value scale pricing methodology. We have chosen to adopt a different payment rate in such instances to ensure that the services currently covered under the Plan can continue to be covered by the federally-administered PCIP while also addressing the need to further contain program costs. These rates were chosen because the federally-administered PCIP can immediately operationalize them. Given the short remaining life of the program, and the limited number of covered services to which these payment rates would apply, we believe, it would be inefficient and too costly for HHS to operationalize other payment rates that could be applied to these covered services. We note that a facility or provider will be able to contact the federally-administered PCIP directly to determine the plan allowance for one of these covered services before providing the service to a federally-administered PCIP enrollee. Below, we discuss the specific covered services for which payment will be 50 percent of billed charges or a rate generated using a relative value scale pricing methodology.

To the extent to which these covered services are non-pharmaceutical services, the payment rate will be calculated using a the relative value scale payment methodology that uses a relative value scale generally based on the difficulty, time, work, risk and resources of the service. For pharmaceutical services other than those administered under the current Plan prescription drug benefit, the relative value scale payment methodology is similar to the pricing methodology used for Medicare Part B drugs based on published acquisition costs or average wholesale price for pharmaceuticals as published in the Red Book by RJ Health Systems, Thomson Reuters. In these cases the plan allowance will be based on the above described relative value scale pricing methodology and subject to the prohibition on balance billing (discussed below). If no Medicare payment rate or relative value scale pricing methodology is available, the federally-administered PCIP will apply the 50 percent of billed charges payment rate. In these cases, the plan allowance is also subject to the prohibition on balance billing (discussed below).

Other instances where covered services will be paid at 50 percent of billed charges are—(1) Professional services where there are no comparable CPT codes; (2) facility based services where the facility does not participate in Medicare and therefore has no Medicare ID; (3) facility-based services where Medicare rates are not yet available or not yet incorporated into the payment software; (4) facility-based services provided in a free-standing facility for skilled nursing facilities, long-term acute care facilities, rehabilitation facilities, mental health and substance abuse facilities; (5) facility-based services where all data elements required to calculate the Medicare payment rate are not provided; (6) facility-based services for home health providers (UB billers only); and (7) covered services that are not covered by Medicare. In these cases the plan allowance will be based on 50 percent of billed charges and subject to the prohibition on balance billing (discussed below). Enrollees will, however, remain responsible for paying any applicable cost-sharing amounts, as calculated by the Plan.

We are adopting these new payment rates for the federally-administered PCIP based on current enrollment projections and the current rate of claims payment. If these enrollment and claims projections change after this interim final rule goes into effect, HHS may opt, through future rulemaking, to change the payment rate.

Given the changes we have already made to the prescription drug benefit in the federally-administered PCIP as previously discussed, we believe that establishing new payment rates for prescription drugs is not administratively feasible or cost effective. Therefore, the current plan allowances that apply to the prescription drug benefit in the federally-administered PCIP will not be affected by this interim final rule and will continue to apply. Similarly, we will not apply the new payment rates to covered services furnished under the organ/tissue transplant benefit to ensure that enrollees continue to have access to the federally-administered PCIP's network of transplant centers of excellence, which we believe will lead to fewer complications, shorter lengths of stay, fewer readmissions, better health outcomes, and lower costs. Accordingly, the current plan allowances for covered services furnished under the organ/tissue transplant benefit will remain the same. Also, we will not apply a new payment rate to the dialysis services provided under the diagnostic and treatment services benefit because we are unable to operationalize a Medicare payment rate. We believe that the current negotiated rates with dialysis providers result in payments that are likely to be less than 50 percent of billed charges. Therefore, we believe maintaining our current in-network payment rate for this service is more competitive than if we were to implement a new payment rate at 50 percent of the billed charge. Finally, we will not apply the new payment rates to covered services furnished under the durable medical equipment benefit, which currently is provided to enrollees in the federally-administered PCIP on an in-network basis only. We believe that the rates currently paid for durable medical equipment are at least as competitive as Medicare payment rates.

This interim final rule establishes new payment rates for most covered services furnished in the federally-administered PCIP. The federally-administered PCIP is administered directly by HHS. We note that HHS can implement this interim final rule quickly and efficiently. The state-based PCIPs have previously indicated to HHS that they are unable to implement new facility and provider rates quickly. Therefore, we have taken the contracting strategy outlined herein with state-based PCIPs.

B. Premiums and Cost-Sharing (§ 152.21(c))

Section 1101(c)(2)(D) of the Affordable Care Act requires that a PCIP program established under this section meet “any other requirements determined appropriate” by the Secretary. We are using this authority to adopt a new requirement for the federally-administered PCIP that conditions a facility or provider's acceptance of the new payment rates discussed above for most covered services on the facility or provider's agreement not to balance bill the enrollee for an amount greater than the cost-sharing amount calculated by the Plan.

Balance billing is a term generally used to describe the practice of billing a patient for the difference between the plan allowance for a covered service and the amount that the facility or provider would otherwise charge for the service. Although the federally-administered PCIP currently contracts with a network of facilities and providers that have agreed not to balance bill, it may not be able to sustain that contractual arrangement as it currently exists, or otherwise enter into new contracts with networks that will accept as payment in full the payment rates we are adopting in this interim final rule. Thus, the federally-administered PCIP may operate without a network for most covered services, and the corresponding protection against balance billing that has, to date, been available to enrollees who choose to use network facilities and providers.

Without such protection, enrollees in the federally-administered PCIP could become liable to pay significant out-of-pocket costs for many covered services. We understand that facility and provider charges will often be higher than the rates we are setting in this interim final rule. Allowing this financial liability to transfer to the enrollee could leave federally-administered PCIP enrollees no better off than they would have been if they had no PCIP coverage, and runs counter to the entire PCIP concept, which is to provide affordable health insurance coverage to those who need it most. Also, we believe that the payment rates we are setting in this interim final rule are still better than the alternative, which is leaving facilities and providers with the possibility of having to decide whether to furnish uncompensated care.

Accordingly, to safeguard federally-administered PCIP enrollees from experiencing potentially significant increases in their out-of-pocket costs due to balance billing, we are adding a new § 152.21(c) to our regulations. Beginning with June 15, 2013 dates of service, this new section requires all facilities and providers that accept payment from the federally-administered PCIP for furnishing a covered service to an enrollee (with the exception of covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits) to accept as payment in full the plan allowance for the covered service, which includes the cost-sharing amount calculated by the Plan for the covered service. With respect to these covered services, facilities or providers may not bill the enrollee for an amount greater than the amount determined by the Plan to be the enrollee's cost-sharing amount for the covered service.

The prohibition on balance billing will not apply to covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits because, as explained above, covered services furnished under these benefits will continued to be paid at the existing in-network payment rates. We do not apply the balance billing prohibition to these covered services because it is our desire to encourage federally-administered enrollees to continue to seek treatment for these covered services from in network facilities and providers for the cost-containment reasons described above.

III. Response to Comments

Because of the large number of public comments we normally receive onFederal Registerdocuments, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in theDATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

IV. Waiver of Proposed Rulemaking and the 60-Day Delay in the Effective Date

Under the Administrative Procedure Act (APA) (5 U.S.C. 551, et seq.), a notice of proposed rulemaking and an opportunity for public comment are generally required before promulgation of a regulation. We also ordinarily provide a 60-day delay in the effective date of the provisions of a rule in accordance with the APA (5 U.S.C. 553(d)), which requires a 30-day delayed effective date and the Congressional Review Act (5 U.S.C. 801(a)(3)), which requires a 60-day delayed effective date for major rules.

However, this procedure can be waived if the agency, for good cause, finds that notice and public comment and delay in effective date are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. 5 U.S.C. 553(d)(3); 5 U.S.C. 808(2).

HHS has determined that issuing this regulation in proposed form, such that it would not become effective until after public comments are submitted, considered, and responded to in a final rule, would be impracticable and contrary to the public interest. The PCIP program is intended to provide benefits to eligible uninsured individuals with pre-existing conditions until 2014. However, the funding available to pay claims against, and the administrative costs of, the PCIP program is limited by statute, and HHS estimates that, at the current rate of expenditure, the aggregate amount needed for the payment of program expenses may be greater than the amount of remaining funding appropriated by the Congress to pay such expenses. Moreover, for individuals with pre-existing conditions enrolled in the PCIP program, the program may be their only available source of health coverage before prohibitions on discrimination by health insurance issuers based on pre-existing conditions go into effect in January 2014. It is critical to the continued sustainability of the program that the new payment rates go into effect as soon as operationally possible. A delay in the implementation of the new reimbursement rates beyond June 15, 2013 would risk program funds being exhausted prior to 2014.

We also believe that it would be impracticable and contrary to the public interest to delay the implementation of a policy that prohibits facilities and providers from billing federally-administered PCIP enrollees for the difference between the plan allowance for most covered services and the amount they would otherwise charge for the covered services. The PCIP program is a program of last resort for individuals who, because of their pre-existing conditions, are either denied coverage in the individual market altogether, or can only obtain coverage that excludes their pre-existing condition (often at substantially higher premium rates than those paid by other individuals). The Affordable Care Act not only makes coverage available to these individuals until the more general pre-existing condition protections become available in 2014, but does so at a lower cost than they otherwise would likely have to pay if they did not have health coverage. Furthermore, if the network currently in place in the federally-administered PCIP became unavailable as a result of the new payment rates being set in this interim final rule, we are concerned that the balance billed charges could cause irreparable financial harm to enrollees and deter them from seeking services at all. Because we want not only to preserve the program benefit structure as intended by the Congress, but also meet the needs of enrollees in the federally-administered PCIP who expect that their out-of-pocket costs will be limited, we believe that it would be impracticable and contrary to the public interest to create a situation in which these enrollees are either deterred from seeking covered benefits under the program altogether, or are forced to pay substantially higher out-of-pocket costs than they would have otherwise had to pay absent our adoption of a policy prohibiting balance billing in this interim final rule.

For the foregoing reasons, we find good cause to waive the notice of proposed rulemaking and 60-day delay in the effective date and to issue this final rule on an interim basis.

We are providing a 60-day public comment period, and this regulation will be effective on June 15, 2013.

V. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in theFederal Registerand solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval.

We are not soliciting public comment on these issues addressed in this interim final rule because we are not making changes to the information collections associated with this program, which are covered under OMB Control Number OMB-0938-1100.

Section 1101 of Title I of the Affordable Care Act requires that the Secretary establish, either directly or through contracts with states or nonprofit private entities, a temporary high risk pool program to provide affordable health insurance benefits to eligible uninsured individuals with pre-existing conditions. The Affordable Care Act envisions that this program will provide coverage to eligible uninsured individuals with preexisting conditions until 2014, when these individuals will begin to have access to a broader range of affordable health coverage options, including qualified health plans offered through new Health Insurance Exchanges established under sections 1311 or 1321 of the Affordable Care Act. An interim final rule published July 10, 2010 (75 FR 45014) set forth and addressed key issues regarding administration of the program, eligibility and enrollment, benefits, premiums, funding, appeals rules, and enforcement provisions related to anti-dumping and fraud, waste, and abuse. This interim final rule sets forth new payment rates that apply to most covered services with dates of service beginning June 15, 2013, in the federally-administered PCIP. Payment rates for covered services—with the exception of covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits will be—(1) 100 percent of Medicare payment rates; or (2) where Medicare payment rates cannot be implemented by the federally-administered PCIP, 50 percent of billed charges or a rate generated using a relative value scale pricing methodology. This interim final rule is an exercise of our authority to make program changes that we have determined are prudent and necessary to ensure that there is sufficient funding to pay for program expenses until 2014.

Additionally, to protect federally-administered PCIP enrollees from potentially becoming financially liable to pay significant costs for covered services as an unintended consequence of this interim final rule, we are adopting a policy that prohibits facilities and providers from billing an enrollee for the difference between the plan allowance for a covered service (with the exception of covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits) and the amount that they would otherwise charge for the covered service. In other words, facilities and providers that furnish covered services to federally-administered PCIP enrollees must accept, as payment in full, the plan allowance for most of those covered services (as determined by the Plan) and not bill the enrollee for an amount greater than the cost-sharing amount that the federally-administered PCIP has calculated for the covered service.

Executive Order 12866 explicitly requires agencies to take account of “distributive impacts” and “equity.” Setting the federally-administered PCIP payment rates applicable to most covered services with dates of service beginning on June 15, 2013, is prudent and necessary to ensure the PCIP program continues to provide benefits to enrolled individuals with pre-existing conditions who cannot obtain health coverage in the existing insurance market until 2014, when these individuals will begin to have access to a broader range of coverage options, including qualified health plans offered through new health insurance marketplaces established under sections 1311 or 1321 of the Affordable Care Act. Based on enrollment and claims data, current HHS estimates indicate that the aggregate amount needed to pay for PCIP expenses may be greater than the remaining funding appropriated by Congress to pay for such expenses until coverage under the program ends in 2014. Therefore, it is critical that we set the new payment rates and prohibit balance billing under the federally-administered PCIP as soon as operationally possible so that we can ensure that funding remains available to provide benefits to PCIP enrollees until 2014 and enrollees are protected from potentially significant out-of-pocket costs.

B. Executive Order 12866

Under Executive Order 12866 (58 FR 51735), a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB). Section 3(f) of the Executive Order defines a “significant regulatory action” as an action that is likely to result in a rule— (1) having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creatinga serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. OMB has determined that this regulation is economically significant within the meaning of section 3(f)(1) of the Executive Order, because it is likely to have an annual effect on the economy of $100 million in at least 1 year. Accordingly, OMB has reviewed this rule pursuant to the Executive Order.

HHS provides an assessment of the potential costs, benefits, and transfers associated with this interim final regulation, summarized in the following table.

Table 1.1— Accounting TableBenefits:Qualitative: The reduction in per-claim costs paid by the federally-administered Pre-Existing Condition Insurance Plan will help to ensure that the PCIP program can continue providing benefits to current enrollees who were previously denied health coverage due to their pre-existing condition. Facilities and providers serving enrollees in the Plan will continue to receive payment for such care, rather than risk receiving no payment for such care should they choose to continue treating the enrollee and PCIP program funding is exhausted prior to 2014.Costs:Qualitative: Health care facilities and providers will get paid less by the Plan for the same covered services, although given the small number of PCIP enrollees and large amount of uncompensated care that might otherwise be sought by these enrollees, we estimate this cost is minimal.a. Estimated Number of Affected Entities

This interim final rule sets new payment rates for most covered services in the federally-administered Pre-Existing Condition Insurance Plan (PCIP) furnished beginning on June 15, 2013. It also prohibits a facility or provider from balance billing a federally-administered PCIP enrollee in most circumstances.

Only facilities and providers furnishing covered services to federally-administered PCIP enrollees will be affected by the new payment rates and prohibition on balance billing. Although payment rates will be reduced, facilities and providers choosing to continue to furnish covered services to PCIP enrollees will continue to receive payment, whereas in the absence of PCIP, they might not be able to continue treating the individuals unless they furnish uncompensated care. Although the federally-administered PCIP currently includes an in-network benefit, enrollees are also able to receive treatment out-of-network, thereby making it difficult to quantify the number of facilities and providers that will be affected by this interim final rule.

b. Benefits

A key premise for the establishment of the PCIP program was that those who are unable to purchase private health insurance coverage due to a pre-existing condition are potentially disadvantaged as a result of both poor health and loss of income. We expect that this interim final regulation will help more than 100,000 current enrollees continue to receive coverage until 2014. According to the 2009 report entitled “Financial and Health Burden of Chronic Conditions Grow,” released by the Center for Studying Health System Change, about 60 percent of the uninsured who have chronic conditions delay care or did not fill a prescription due to cost. Lack of health coverage often leads to significant medical debt, and uncompensated and expensive care at sites such as emergency rooms, shifting these costs in the health system to people with insurance coverage to offset the cost of this uncompensated care. Given these potential consequences of PCIP enrollees losing coverage and becoming uninsured prior to the coverage protections that will go into effect in 2014, this interim final regulation could generate significant benefits to enrolled individuals, for whom it will be possible to continue to be enrolled in the PCIP program. Absent this interim final rule, the PCIP program could exhaust its $5 billion in appropriated funding before the end of the program in 2014.

The Regulatory Impact Analysis included in the preamble to the 2010 PCIP interim final regulation included a discussion of the PCIP program's benefit to program-eligible individuals, as compared to the absence of the program. This interim final rule better ensures the continued existence of the program until 2014, as an alternative to the absence of the program during that time period. Therefore, we refer readers to the discussion of the benefits to program-eligible individuals that appears in the Regulatory Impact Analysis of the July 30, 2010 interim final regulation (75 FR 45026). These benefits could take the form of reductions in mortality and morbidity, reductions in medical expenditure risk, and increases in worker productivity. Each of these effects is described in that Regulatory Impact Analysis.

c. Costs and Transfers

Under Section 1101 of the Affordable Care Act, HHS is authorized to disperse $5 billion to pay claims and the administrative costs of the PCIP program that are in excess of premiums collected from enrollees.

There will be administrative costs associated with this interim final rule. The federally-administered PCIP claims processing contractor will incur minimal administrative costs to implement the payment rates required by this regulation to ensure that its systems are properly coded to pay the payment rates established under this interim final rule. This cost will be minimal because the claims processing contractor has an existing system in place to adjust its payment rates to reduce the payment rates to the amount specified.

This interim final rule will not increase or decrease costs to the federal government. The Congress appropriated $5 billion for the PCIP program, and HHS intends to spend that $5 billion for PCIP-related costs, although this regulation will change how a portion of the remaining $5 billion is distributed by spreading funding for the maximum period of time by setting new payment rates in the federally-administered PCIP.

With respect to other parties, we lack data with which to quantify costs associated with this regulation. Setting new payment rates for most covered services under the federally-administered PCIP program gives facilities and providers two choices. One choice is to continue to treat federally-administered PCIP enrollees and accept the payment rates set by this regulation as payment in full. We acknowledge that facilities and providers would, in general, be paid less to treat PCIP enrollees but we believe such cost is minimal (relative to facilities and providers' annual revenues). In the absence of this regulation, funding for the PCIP program may be exhausted prior to 2014, causing enrollees to seek from the same facilities and providers uncompensated and expensive care. Facilities and providers who furnish covered services to individuals enrolled in the federally-administered PCIP, the anticipated reduction in PCIP revenue per claim will not, in the aggregate, eliminate their overall PCIP revenue.The other choice that facilities and providers have is to no longer treat PCIP enrollees. While we understand that the decision to no longer treat PCIP enrollees is possible, we believe and are hopeful that most facilities and providers will accept the new payment rates established in this interim final rule given the serious health conditions many federally-administered PCIP enrollees have and the prospect that such reduced payment is temporary until 2014 when no one can generally be denied health coverage because of a pre-existing condition. Facilities or providers who choose to not accept the payment rates established in this interim final rule could limit a federally-administered PCIP enrollee's ability to access health care services. However, this same possibility would occur if the PCIP program were to end before 2014. Lastly, because the PCIP program serves such a small population nationwide, and the program is temporary in nature, it is unlikely that a facility or provider's annual revenue would be significantly impacted by continuing to treat PCIP enrollees at the new payment rate. Therefore, we believe that this interim final regulation has minimal cost to such providers and facilities.

d. Conclusion

Under section 1101 of the Affordable Care Act, HHS is authorized to spend $5 billion for the purpose of funding the PCIP program. Implementing this interim final regulation, through which HHS is setting payment rates for most covered services under the federally-administered PCIP program to 100 percent of Medicare payment rates, may not impose any substantial financial costs on any parties.

For facilities and providers, the anticipated reduction in PCIP revenue per claim will likely be offset by the cost of uncompensated care in the absence of the PCIP program, a cost that facilities and providers would frequently incur if the PCIP program terminated earlier than 2014, due to funds being exhausted. Therefore, this interim final regulation has, in aggregate, minimal cost to such facilities and providers. By ensuing that coverage continues through the end of the year, when new options become available, the payment rates set forth in this interim final regulation will likely have a significant, positive financial impact on individuals enrolled in the program.

We anticipate that PCIP enrollees, who might otherwise lose their PCIP coverage will benefit from this interim final rule because they will be able to maintain their PCIP coverage. We also anticipate that ensuring the PCIP program's existence through 2014 will reduce the burden on local and state governments to pay health care facilities and providers for uncompensated care and prevent shifting of uncompensated care costs in the health system to people with insurance coverage to offset the cost of such uncompensated care.

VII. Other SectionsRegulatory Alternatives

Under the Executive Order, we must consider alternatives to issuing regulations and alternative regulatory approaches. This interim final rule sets payment rates for covered services in the federally-administered PCIP with dates of service beginning June 15, 2013 to reduce the rate of expenditures in order to eliminate the potential funding deficit estimated to occur in calendar year 2013. While other program modifications, as previously summarized, have been implemented to contain program costs, no other viable alternatives were identified that could substitute for the changes included in this interim final rule.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as—(1) A proprietary firm meeting the size standards of the Small Business Administration (SBA); (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of “small entity.” The Secretary certifies that this interim final rule will not have significant impact on a substantial number of small entities.

Unfunded Mandates Reform Act

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require certain spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2013, that threshold is approximately $141 million.

UMRA does not address the total cost of a rule. Rather, it focuses on certain categories of cost, mainly those “federal mandate” costs resulting from—(1) Imposing enforceable duties on state, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, state, local, or tribal governments under entitlement programs.

Under the Affordable Care Act, states (or their designated nonprofit, private entities) chose to contract with HHS to administer PCIP and receive federal funding for doing so. If they did not choose to administer a PCIP, HHS established a PCIP in the state. Thus, this interim final rule does not impose an unfunded mandate on states.

Enrolled individuals have to pay a premium and other out-of-pocket expenses to maintain their enrollment in a PCIP. However, individuals are free to disenroll based on their evaluation of the costs and benefits of remaining in the program. There is no automatic enrollment and no requirement to enroll or remain enrolled in a PCIP. Thus, this interim final rule does not impose an unfunded mandate on the private sector.

Federalism (Executive Order 13132)

Under the specific provisions of the Affordable Care Act, States or State-delegated non-profit entities are contractors of the HHS in the implementation of the PCIP program. HHS has given those contractors flexibility within the parameters provided by the Affordable Care Act and within the budgetary capacity of the program.

Congressional Review Act

This proposed regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq) and has been transmitted to the Congress and Comptroller General for review.

V. Statutory Authority

This interim final rule is adopted pursuant to the authority contained in section 1101 of the Patient Protection and Affordable Care Act (Pub. L. 111-148).

2. Section 152.21 is amended by adding paragraph (c) to read as follows.§ 152.21Premiums and cost-sharing.

(c)Prohibition on balance billing in the PCIP administered by HHS.A facility or provider that accepts payment under § 152.35(c)(2) for a covered service furnished to an enrollee may not bill the enrollee for an amount greater than the cost-sharing amount for the covered service calculated by the PCIP.

(c)Payment rates for covered services furnished beginning June 15, 2013 to enrollees in the PCIP administered by HHS.(1) Covered services furnished under the prescription drug, organ/tissue transplant, dialysis and durable medical equipment benefits will be paid at the payment rates that are in effect on June 15, 2013.

(2) With respect to all other covered services, the payment rates will be—

(i) 100 percent of Medicare payment rates; or

(ii) Where Medicare payment rates cannot be implemented by the federally-administered PCIP, 50 percent of billed charges or a rate using a relative value scale pricing methodology.

In this document, the Commission adopts rules to implement section 718 of the Communications Act of 1934 (the Act), as amended, which was added to the Act by the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA). Section 718 of the Act requires Internet browsers built into mobile phones to be accessible to individuals who are blind or visually impaired. In this document, the Commission also affirms that section 716 of the Act requires certain Internet browsers used for advanced communications services to be accessible to people with disabilities.

This is a summary of the Commission's Second Report Order, document FCC 13-57, adopted on April 26, 2013, and released on April 29, 2013, in CG Docket No. 10-213, WT Docket No. 96-198, and CG Docket No. 10-145. The full text of document FCC 13-57 will be available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone: (800) 378-3160, fax: (202) 488-5563, or Internet:www.bcpiweb.com.Document FCC 13-57 can also be downloaded in Word or Portable Document Format (PDF) athttp://www.fcc.gov/document/section-718-accessibility-requirements-internet-browsers-mobile.To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email tofcc504@fcc.govor call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice) or (202) 418-0432 (TTY).

Final Paperwork Reduction Act of 1995 Analysis

Document FCC 13-57 does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4).

SynopsisI. Introduction

1. In document FCC 13-57, the Commission implements section 718 of the Act, which was added by section 104 of the CVAA to ensure that people with disabilities have access to emerging and innovative advanced communications technologies. Section 718 of the Act requires mobile phone manufacturers and mobile service providers that include or arrange for the inclusion of an Internet browser on mobile phones to ensure that the functions of the included browser are accessible to and usable by individuals who are blind or have a visual impairment, unless doing so is not achievable. In addition, in document FCC 13-57, the Commission affirms its previous conclusions regarding the coverage of Internet browsers used for ACS under section 716 of the Act, and retains the recordkeeping requirements and deadlines for entities covered under section 718 of the Act.

II. Background

2. On October 7, 2011, the Commission adopted rules, published at 76 FR 82353, December 30, 2011, implementing section 716 of the Act (also added by the CVAA), which requires advanced communications services (ACS) and equipment used for ACS to be accessible to and usable by individuals with disabilities, unless doing so is not achievable. 47 U.S.C. 617; 47 CFR 14.1—14.21 of the Commission's rules. The Commission also adopted rules to implement section 717, which establishes recordkeeping and enforcement requirements for entities covered under sections 255, 716, and 718 of the Act. 47 U.S.C. 618; 47 CFR 14.30—14.52 of the Commission's rules. In addition, the Commission adopted a Further Notice ofProposed Rulemaking (ACS FNPRM), published at 76 FR 82240, December 30, 2011, that sought comment on rules to implement section 718. Among other things, the Commission raised the following issues in theACS FNPRM:(1) Coverage of Internet browsers under section 716 and section 718; (2) the best ways to implement section 718 to achieve compliance by the time the provision goes into effect; (3) accessibility application programming interfaces (APIs); and (4) the recordkeeping requirements.

III. Coverage of Internet Browsers Under Section 716 and Section 718A. General Coverage of Internet Browsers Under Section 716 of the Act

3. In document FCC 13-57, the Commission affirms its previous conclusion that equipment with manufacturer-installed or included Internet browsers used for ACS are encompassed within the term “equipment used for ACS” subject to section 716 of the Act. Likewise, the Commission affirms that an ACS provider is responsible for the accessibility of the underlying components of its service, including any software, such as an Internet browser, that it provides. Among other things, this means that the functions of an Internet browser—to enable users, for example, to input a uniform resource locator (URL) into the address bar; to identify and activate home, back, forward, refresh, reload, and stop buttons; to view status information; and to activate zooming or other features that are used for ACS—must be accessible to individuals with disabilities, unless doing so is not achievable.

4. In document FCC 13-57, the Commission concludes that Internet browsers do not “pass through” information to independent downstream devices, software, or applications, as that term is used in section 14.20(c) of the Commission's rules. Nevertheless, the Commission notes that covered entities are not relieved of their obligations to ensure the accessibility of browsers included by manufacturers or service providers under section 716 of the Act. For example, if a covered entity installs or directs the installation of an Internet browser, and the browser supports a specific web standard, approved standards recommendations, or technology that includes the capabilities to support accessibility features and capabilities, it must ensure that the Internet browser can use such capabilities contained in those standards or technologies to support the intended accessibility features and capabilities in the ACS web application retrieved and displayed by the browser, unless doing so is not achievable. To the extent that an included Internet browser does not support a particular technology that is needed to make web-based information available to the general public, the Commission declines to require covered entities to ensure that such browsers support the technology solely for the purpose of achieving accessibility.

B. Overlapping Coverage of Internet Browsers Under Sections 716 and 718 of the Act

5. In document FCC 13-57, the Commission finds that, with respect to individuals with disabilities generally, section 716(a) of the Act covers manufacturers of all equipment (including mobile phones) that include an Internet browser used for ACS, and section 716(b) of the Act covers ACS providers (including mobile service providers that provide ACS) that provide or require the installation and use of an Internet browser as an underlying component of their ACS. The Commission further finds that, specifically with respect to individuals who are blind or visually impaired, section 718 of the Act covers manufacturers of mobile phones that include an Internet browser used for any purpose, as well as mobile service providers who arrange for the inclusion of an Internet browser used for any purpose.

IV. Implementation of Section 718

6. Except as otherwise noted, in document FCC 13-57, the Commission adopts rules for section 718 of the Act that are analogous to the Commission's Part 14 rules implementing section 716. Specifically, the rules adopted define the terms “accessible” and “usable” as the Commission previously defined these terms when implementing sections 716(a)(1) and (b)(1) and sections 255(b) and (c) of the Act. The Commission also adopts key requirements similar to those in its section 255 and section 716 rules regarding product design, development, and evaluation. Entities subject to section 718 of the Act must consider performance objectives at the design stage as early as possible and identify barriers to accessibility and usability as part of their evaluation when considering implementation of the accessibility performance objectives. 47 CFR 14.20(a) and (b) of the Commission's rules. Entities subject to section 718 of the Act must also ensure that information and documentation that they provide to customers are accessible, if achievable. 47 CFR 14.20(d) of the Commission's rules.

7. The Commission declines to apply the information pass-through requirement in section 14.20(c) of the Commission's rules to entities covered under section 718 of the Act. Nevertheless, the Commission notes that covered entities are not relieved of their obligations under section 718 of the Act. A covered entity that installs or directs the installation of an Internet browser that supports a specific web standard, approved standards recommendations, or technology that includes the capabilities to support accessibility features and capabilities, must ensure that the Internet browser can use such capabilities contained in those standards or technologies to support the intended accessibility features and capabilities in the web application retrieved and displayed by the browser, unless doing so is not achievable. To the extent that an included Internet browser does not support a particular technology that is needed to make web-based information available to the general public, the Commission declines to require covered entities to ensure that such browsers support the technology solely for the purpose of achieving accessibility.

8. Section 716(g) of the Act defines the term “achievable” for the purposes of both section 716 and section 718 to mean “with reasonable effort or expense, as determined by the Commission” and requires consideration of four specific factors when making such determinations. In document FCC 13-57, the Commission defines and applies the term “achievable” to entities covered under section 718(a) of the Act in the same manner as this term is defined in section 716(g) of the Act and as it is applied to entities covered under sections 716(a)(1) and (b)(1) of the Act.

9. In document FCC 13-57, the Commission defines and applies the industry flexibility provisions contained in section 718(b) of the Act in the same manner as these provisions are defined and applied in sections 716(a)(2) and (b)(2) of the Act. These provisions allow industry the flexibility to satisfy their respective accessibility requirements with or without the use of third party applications, peripheral devices, software, hardware, or customer premises equipment that are available to consumers at nominal cost and that individuals with disabilities can access.

10. The Commission does not apply the compatibility provision contained in section 716(c) of the Act—requiring that, if compliance with the accessibilityrequirements for ACS and equipment used for ACS is not achievable, then such equipment or services must be compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, unless doing so is not achievable—to entities covered under section 718 of the Act, because there is no provision in section 718 parallel to section 716(c) of the Act that would demonstrate Congress's intent for such a requirement. However, the Commission notes that mobile phones that include Internet browsers are generally also subject to the compatibility requirements of section 716(c) of the Act to the extent the mobile phones are used for ACS, such as electronic messaging, and of section 255(d) of the Act to the extent the mobile phones are used for telecommunications service.

11. The Commission also does not apply the provisions in section 716 of the Act governing exemptions from the accessibility requirements for customized equipment or services, and waivers for small entities and multipurpose services and equipment to section 718 of the Act, because section 718 contains no parallel exemption or waiver provisions. Nevertheless, the Commission notes that an entity covered by section 718 of the Act may petition for a waiver of the Commission's rules implementing section 718 pursuant to the Commission's general waiver provisions contained at 47 CFR 1.3 of the Commission's rules.

V. Accessibility Application Programming Interfaces

12. An API is software that an application program uses to request and carry out lower-level services performed by the operating system of a computer or telephone. An accessibility API, in turn, is a specialized interface developed by a platform owner which can be used to communicate accessibility information about user interfaces to assistive technologies. Because there are various methods to achieve compliance with the section 718 of the Act requirements, and there is a need to afford covered entities flexibility on how to comply, the Commission, at this time, does not mandate that covered entities include accessibility APIs in mobile phones. Further, at this time, the Commission declines to establish the inclusion of an accessibility API in a mobile phone as a safe harbor for compliance with section 718 of the Act.

VI. Recordkeeping Requirements

13. Section 717(a)(5)(A) of the Act requires, beginning January 30, 2013, each manufacturer and service provider subject to sections 255, 716, and 718 of the Act to maintain records of its efforts to implement sections 255, 716, and 718, including the following: information about its efforts to consult with individuals with disabilities; descriptions of the accessibility features of its products and services; and information about the compatibility of its products and services with equipment commonly used by individuals with disabilities to achieve access. In October 2011, the Commission adopted recordkeeping requirements implementing this statutory requirement. In theACS FNPRM,the Commission sought comment on whether these recordkeeping requirements should be retained or altered for entities covered under section 718 of the Act. In document FCC 13-57, the Commission retains the recordkeeping requirements as adopted and declines to delay implementation for entities covered under section 718 of the Act.

Final Regulatory Flexibility Analysis

14. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 603, an Initial Regulatory Flexibility Analysis (IRFA) was included in theACS FNPRMin CG Docket No. 10-213, WT Docket No. 96-198, and CG Docket No. 10-145. The Commission sought written public comment on the proposals in these dockets, including comment on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

A. Need for, and Objectives of, the Second Report and Order

15. In document FCC 13-57, the Commission adopts rules to implement section 718 of the Act, which was added by the CVAA. Specifically, section 718(a) of the Act requires a mobile phone manufacturer that includes an Internet browser or a mobile phone service provider that arranges for an Internet browser to be included on a mobile phone to ensure that the browser functions are accessible to and usable by individuals who are blind or have a visual impairment, unless doing so is not achievable. Under section 718(b) of the Act, mobile phone manufacturers or service providers may achieve compliance with or without the use of third party applications, peripheral devices, software, hardware, or customer premises equipment. Congress provided that the effective date for these requirements is three years after the enactment of the CVAA, which is October 8, 2013.

16. In document FCC 13-57, the Commission finds that sections 716 and 718 of the Act, which were both adopted by the CVAA, have overlapping requirements. Specifically, section 716 of the Act applies to all Internet browsers that are built into equipment and used for ACS or that may be required to be installed by ACS equipment manufacturers or providers. Section 718 of the Act applies only to the discrete category of Internet browsers built into mobile phones used for any purpose (not just to access ACS) by a discrete group of individuals with disabilities, that is, people who are blind or have a visual impairment.

17. In document FCC 13-57, the Commission adopts rules for section 718 of the Act that are consistent with the Commission's rules implementing section 716 of the Act. 47 CFR 14.1-14.21 of the Commission's rules. For the purpose of applying section 718(a) of the Act, the terms “accessible” and “usable” are defined in the same manner as these terms are applied to entities covered under sections 716(a)(1) and (b)(1) of the Act. Because section 716(g) of the Act defines “achievable” for purposes of both sections 716 and 718, the Commission defines and applies the term “achievable” to entities covered under section 718 of the Act in the same manner as entities covered under section 716 of the Act. Because sections 716(a)(2) and (b)(2) of the Act are virtually identical to section 718(b) of the Act, the Commission defines and applies the industry flexibility provisions contained in section 718(b) of the Act in the same manner as these provisions are defined and applied in section 716 of the Act.

18. Section 716 of the Act includes specific exemptions for customized equipment or services, and gives the Commission authority to waive accessibility requirements for small entities and multipurpose services and equipment. Because section 718 of the Act contains no parallel exemption or waiver provisions, the Commission finds insufficient basis to establish similar exemptions and waiver provisions specific to the requirements of section 718 of the Act. Nevertheless, an entity covered by section 718 of the Act could petition for a waiver of the Commission's rules implementing section 718 pursuant to the Commission's general waiver provisions requiring petitioners to show good cause to waive the rules, and a showing that the particular facts of the petitioner's circumstances make complianceinconsistent with the public interest. 47 CFR 1.3 of the Commission's rules.

19. In document FCC 13-57, the Commission also declines to require accessibility APIs because there are various methods to achieve compliance with the section 718 of the Act requirements, and there is a need to afford covered entities flexibility on how to comply. Lastly, in document FCC 13-57, the Commission retains the recordkeeping requirements previously adopted for manufacturers and service providers covered under section 718 of the Act. 47 CFR 14.31 of the Commission's rules.

B. Summary of the Significant Issues Raised by the Public Comments in Response to the IRFA

20. No party filing comments in this proceeding responded to the IRFA in regard to implementation of section 718 of the Act, and no party filing comments in this proceeding otherwise addressed whether the policies and rules proposed in this proceeding regarding implementation of section 718 of the Act would have a significant economic impact on a substantial number of small entities.

C. Description and Estimate of the Number of Small Entities to Which the Rules Will Apply

21. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that face possible significant economic impact by the adoption of proposed rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one that (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA. Nationwide, there are a total of approximately 27.9 million small businesses, according to the SBA.

22. The following entities have been identified as entities in which a majority of businesses in each category are estimated to be small. NAICS codes are provided where applicable.

23.Recordkeeping.In document FCC 13-57, the Commission retains the recordkeeping requirements previously adopted, which requires, beginning January 30, 2013, that each service provider and each equipment manufacturer subject to sections 255, 716, and 718 of the Act maintain certain records. 47 CFR 14.31 of the Commission's rules. These records document the efforts taken by a manufacturer or service provider to implement sections 255, 716, and 718 of the Act, and specifically include: (1) Information about the manufacturer's or provider's efforts to consult with individuals with disabilities; (2) descriptions of the accessibility features of its products and services; and (3) information about the compatibility of such products and services with peripheral devices or specialized customer premise equipment commonly used by individuals with disabilities to achieve access.

24.Annual Certification Obligations.The CVAA and the Commission's rules require an officer of each service provider and equipment manufacturer subject to sections 255, 716, and 718 of the Act to submit to the Commission an annual certificate that records are kept in accordance with the above recordkeeping requirements. The certification must be filed with the Consumer and Governmental Affairs Bureau on or before April 1 each year for records pertaining to the previous calendar year. In document FCC 13-57, the Commission makes no changes to these requirements.

25.Achievability Analysis.Section 718(a) of the Act requires that the functions of Internet browsers included in mobile telephones “are accessible to and usable by individuals who are blind or have a visual impairment, unless doing so is not achievable. . . .” Section 716(g) of the Act, in turn, defines achievable as meaning “with reasonable effort or expense. . . .” The statute goes on to provide a four factor test to assess achievability. Two of the factors—(1) the nature and costs of the steps needed to meet the requirements with respect to the specific equipment or service in question and (2) the technical and economic impact on the operation of the manufacturer or provider and on the operation of the specific equipment or service in question, including on the development and deployment of new communications technologies—specifically take into account the cost of meeting the requirements and the financial resources available to the equipment manufacturer or service provider. As a result, the initial cost of compliance is to perform the achievability analysis itself, which we estimate to be a small incremental cost when compared to the cost of developing the Internet browser. After the achievability analysis is conducted, the additional cost of making the equipment or service accessible to and usable by individuals who are blind or have a visual impairment is fact specific—it is dependent upon the design of the Internet browser and the accessibility features that are needed. In this regard, because the Internet browser is required to be accessible only if achievable, and because the achievability analysis takes into consideration the cost of providing accessibility as well as the financial resources of the manufacturer or service provider, the requirement to undertake an achievability analysis prevents the accessibility requirements adopted in document FCC 13-57 from having a significant economic impact on small entities.

E. Steps Taken To Minimize Significant Economic Impact on Small Entities and Significant Alternatives Considered

26. The RFA requires an agency to describe any significant alternatives it considered in developing its approach, which may include the following four alternatives, among others: “(1) The establishment of differing compliance or certification requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and certification requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”

27. In document FCC 13-57, the Commission continues and preserves the steps taken previously to minimize adverse economic impact on small entities. Specifically, in document FCC 13-57, the Commission continues to promote flexibility for all entities in several ways. The rules require covered entities to ensure that Internet browsers included in mobile phones are accessible, unless not achievable. This is a statutory requirement; therefore no alternatives were considered. However, this requirement has built-in flexibility. All entities, including small entities, may build accessibility features into the product or may rely on third party applications, peripheral devices, software, hardware, or customerpremises equipment to meet their obligations under section 718 of the Act, if achievable. Achievability is determined through a four factor analysis, described above. Through this analysis, an otherwise covered entity can demonstrate that accessibility is not achievable. Two of the four factors are particularly relevant to small entities: the nature and cost of the steps needed to meet the section 716 of the Act requirements and the technical and economic impact on the entity's operations. If achievability is overly expensive or has some significant negative technical or economic impact on a covered entity, the entity can show that accessibility was not achievable as a defense to a complaint. This achievability analysis, therefore, provides a statutorily based means of minimizing the economic impact of the CVAA's requirements on small entities.

28. The rules adopted in document FCC 13-57 require covered entities to consider performance objectives at the design stage as early and consistently as possible. This requirement is necessary to ensure that accessibility is considered at the point where it is logically best to incorporate accessibility. The CVAA and document FCC 13-57 are performance-driven and avoid mandating particular designs. Instead, they focus on an entity's compliance with the accessibility requirements through whatever means the entity finds necessary to make its product or service accessible, unless not achievable. This provides flexibility by allowing each entity, including small entities, to individually meet its obligations through what works best for that given entity (given the accessibility needs of the consumers being served), instead of mandating a rigid requirement that applies to all covered entities.

29. In document FCC 13-57, the Commission also leaves unchanged the requirements adopted previously that allow covered entities to keep records in any format they wish, because this flexibility affords small entities the greatest flexibility to choose and maintain the recordkeeping system that best suits their resources and their needs. The Commission found that this approach takes into account the variances in covered entities (e.g.,size, experience with the Commission), recordkeeping methods, and products and services covered by the CVAA. Moreover, the Commission found that it provided the greatest flexibility for small businesses and minimized the economic impact that the statutorily mandated requirements impose on small businesses. Correspondingly, the Commission considered and rejected the alternative of imposing a specific format or one-size-fits-all system for recordkeeping that could potentially impose greater burdens on small businesses. In addition, in document FCC 13-57, the Commission leaves unchanged the certification requirement, which is also required by the statute.

30. Although section 718 of the Act contains no exemption or waiver provisions comparable to those in section 716 of the Act, in document FCC 13-57, the Commission notes that an entity covered by section 718 of the Act may petition for a waiver of the Commission's rules implementing section 718 pursuant to the general waiver provisions in section 1.3 of the Commission's rules, which requires a showing of good cause to waive the rules, as well as a showing that particular facts make compliance inconsistent with the public interest. Section 1.3 of the Commission's rules therefore affords small entities additional compliance flexibility.

F. Federal Rules that May Duplicate, Overlap, or Conflict With Proposed Rules

31. Section 255(e) of the Act, as amended, directs the Architectural and Transportation Barriers Compliance Board (Access Board) to develop equipment accessibility guidelines “in conjunction with” the Commission, and periodically to review and update those guidelines. The Commission views the Access Board's current guidelines as well as its proposed guidelines as starting points for our interpretation and implementation of sections 716, 717, and 718 of the Act, as well as section 255 of the Act. As such, our rules do not overlap, duplicate, or conflict with either existing or proposed Access Board guidelines on section 255 of the Act.

Congressional Review Act

32. The Commission will send a copy of document FCC 13-57 in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. 5 U.S.C. 801(a)(1)(A).

2. Add subpart E to read as follows:Subpart E—Internet Browsers Built Into Telephones Used With Public Mobile Services.Sec.14.60Applicability.14.61Obligations with respect to internet browsers built into mobile phones.§ 14.60Applicability.

(a) This subpart E shall apply to a manufacturer of a telephone used with public mobile services (as such term is defined in 47 U.S.C. 710(b)(4)(B)) that includes an Internet browser in such telephone that is offered for sale or otherwise distributed in interstate commerce, or a provider of mobile services that arranges for the inclusion of a browser in telephones to sell or otherwise distribute to customers in interstate commerce.

(b) Only the following enumerated provisions contained in this part 14 shall apply to this subpart E.

(1) The limitations contained in § 14.2 shall apply to this subpart E.

(2) The definitions contained in § 14.10 shall apply to this subpart E.

(3) The product design, development and evaluation provisions contained in § 14.20(b) shall apply to this subpart E.

§ 14.61Obligations with respect to internet browsers built into mobile phones.

(a)Accessibility.If on or after October 8, 2013 a manufacturer of a telephone used with public mobile services includes an Internet browser in such telephone, or if a provider of mobile service arranges for the inclusion of a browser in telephones to sell to customers, the manufacturer or provider shall ensure that the functions of the included browser (including the ability to launch the browser) are accessible to and usable by individuals who are blind or have a visual impairment, unless doing so is not achievable, except that this subpart shall not impose any requirement on such manufacturer or provider—

(1) To make accessible or usable any Internet browser other than a browser that such manufacturer or provider includes or arranges to include in the telephone; or

(2) To make Internet content, applications, or services accessible or usable (other than enabling individuals with disabilities to use an included browser to access such content, applications, or services).

(b)Industry flexibility.A manufacturer or provider may satisfy the requirements of this subpart with respect to such telephone or services by—

(1) Ensuring that the telephone or services that such manufacturer or provider offers is accessible to and usable by individuals with disabilities without the use of third-party applications, peripheral devices, software, hardware, or customer premises equipment; or

(2) Using third-party applications, peripheral devices, software, hardware, or customer premises equipment that is available to the consumer at nominal cost and that individuals with disabilities can access.

DoD published a proposed rule in theFederal Registerat 77 FR 51957 on August 28, 2012, to update instructions for assigning basic and supplementary procurement instrument identification numbers (PIIN) by limiting the use of “F” in the 9th position of the PIIN to those orders and calls issued by DoD under indefinite delivery type contracts and agreements issued by departments or agencies outside the DoD. Two respondents submitted public comments in response to the proposed rule.

II. Discussion and Analysis of the Public Comments

DoD reviewed the public comments in the development of the final rule. A discussion of the comments is provided.

A. Summary of Changes from the Proposed Rule

There were no changes made from the proposed rule as a result of the comments.

B. Analysis of public comments1. Information technology

Comment:One respondent was concerned that if AbilityOne and FPI vendors were no longer identified by an “F” in the 9th position of the PIIN, field activities would no longer be able to pull data relating to these awards. The respondent asked what office would be responsible for retrieving such data, and whether a particular system, EProcurement/Records Management, allows for data retrieval via Data Universal Numbering System number and/or Commercial and Government Entity code.

Response:The “F” in the 9th position has not been exclusively utilized for AbilityOne and FPI awards; therefore retrieving data by the “F” in 9th position does not provide a sufficiently discrete result. DoD uses other data elements, such as specific DUNS numbers and validations from the Ability One Program, as indicators for awards to Federal Prison Industries and Ability One vendors.

2. Implementation impact

Comment:One respondent stated that standardizing identification systems would benefit DoD. However, the respondent was concerned that the rule could have an adverse impact on smaller, i.e. AbilityOne and FPI, vendors. The respondent inquired as to whether implementation of the rule would apply to existing awards, and if so, might cause an additional adverse impact.

Response:The revision of the use of “F” in PIINs will have no impact on the smaller AbilityOne and FPI vendors; it is simply an award identifier. DoD uses other data elements, such as specific DUNS numbers and validations from the Ability One Program, as indicators for awards to Federal Prison Industries and Ability One vendors. The final rule is a prospective change to DFARS. Existing award and order numbers will not be changed. DoD anticipates no adverse impacts from implementation of this rule.

III. Executive Orders 12866 and 13563

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

IV. Regulatory Flexibility Act

DoD does not expect this final rule to have a significant economic impact on a substantial number of small entities because it applies to a narrowly limited population of procurement actions however, a final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., and is summarized as follows:

This rule will clarify which contracts are to be coded with an “F” in the 9th position of the PIIN. It is not anticipated that the rule will impact small entities as it only impacts the internal operating procedures of the Government by specifying how the assigned PIIN is constructed for certain procurement actions. This change limits the use of “F” in the 9th position to task and delivery orders and calls issued under a non-DoD issued contract or agreement. As a result of the rule, new awards under the AbilityOne program and the FPI programs will no longer reflect an “F” in the 9th position of the in the PIIN. DoD uses other data elements, such as specific DUNS numbers and validations from the Ability One Program, as indicators for awards to Federal Prison Industries and Ability One vendors.

V. Paperwork Reduction Act

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

List of Subjects in 48 CFR Part 204

Government procurement.

Kortnee Stewart,Editor, Defense Acquisition Regulations System.

Therefore, DoD amends 48 CRF part 204 as follows:

1. The authority citation for part 204 continues to read as follows:Authority:

41 U.S.C. 1303 and 48 CFR Chapter 1.

PART 204—ADMINISTRATIVE MATTERS2. Section 204.7003 is amended by revising paragraphs (a)(3)(iii) and (iv) to read as follows:204.7003Basic PII number.

(a) * * *

(3) * * *

(iii) Contracts of all types except indefinite-delivery contracts, sales contracts, and short form research contracts. Do not use this code for contracts or agreements with provisions for orders or calls.—C

(ii) If an office is placing calls against non-DoD blanket purchase agreements or orders under non-DoD issued contracts (including Federal Supply Schedules, Governmentwide acquisition contracts, and multi-agency contracts), or basic ordering agreements, the office shall identify the instrument with a 13 position supplementary PII number using an F in the 9th position. Do not use the same supplementary PII number with an F in the 9th position on more than one order. Modifications to these calls or orders shall be numbered in accordance with paragraph (c) of this section.

This final rule amends the DFARS to correct typographical error at 204.1105 and to correct the clause date at 252.204-7004, 252.204-7007, 252.232-7006, 252.232-7011, and 252.245-7004.

List of Subjects in 48 CFR Parts 204 and 252

Government procurement.

Manuel Quinones,Editor, Defense Acquisition Regulations System.

Therefore, 48 CFR parts 252 is amended as follows:

1. The authority citation for 48 CFR parts 204 and 252 continues to read as follows:Authority:

41 U.S.C. 1303 and 48 CFR chapter 1.

PART 204—ADMINISTRATIVE MATTERS204.1105[Amended]2. Amend section 204.1105 by removing the word “clause” and adding the word “provision” in its place.PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES252.204-7004[Amended]3. Section 252.204-7004 is amended by removing from the clause heading “(DATE)” and adding “(MAY 2013)” in its place.252.204-7007[Amended]4. Section 252.204-7007 is amended by removing “(DATE)” and adding “(MAY 2013)” in its place.252.232-7006[Amended]5. Section 252.232-7006 is amended by removing “(DATE)” and adding “(MAY 2013)” in its place.252.232-7011[Amended]6. Section 252.232-7011 is amended by removing “(DATE)” and adding “(MAY 2013)” in its place.252.245-7004[Amended]7. Section 252.245-7004 is amended by removing “(DATE)” and adding “(MAY 2013)” in its place.[FR Doc. 2013-12205 Filed 5-21-13; 8:45 am]BILLING CODE 5001-06-PDEPARTMENT OF DEFENSEDefense Acquisition Regulations System48 CFR Parts 209, 227, and 252RIN Number 0750-AG38Defense Federal Acquisition Regulation Supplement; Government Support Contractor Access to Technical Data (DFARS 2009-D031)AGENCY:

Defense Acquisition Regulations System, Department of Defense (DoD).

ACTION:

Final rule.

SUMMARY:

DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2010 that provides authority for certain types of Government support contractors to have access to proprietary technical data belonging to prime contractors and other third parties, provided that the technical data owner may require the support contractor to execute a non-disclosure agreement having certain restrictions and remedies.

DATES:

Effective:May 22, 2013.

FOR FURTHER INFORMATION CONTACT:

Mr. Mark Gomersall, 571-372-6099.

SUPPLEMENTARY INFORMATION:

I. Background

DoD published an interim rule in theFederal Registerat 76 FR 11363 on March 2, 2011, to implement section 821 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111-84), enacted October 28, 2009. Section 821 provides authority for certain types of Government support contractors to have access to proprietary technical data belonging to prime contractors and other third parties, provided that the technical data owner may require the support contractor to execute a non-disclosure agreement having certain restrictions and remedies.

The DFARS scheme for acquiring rights in technical data is based on 10 U.S.C. 2320 and 2321. Section 2320 establishes the basic allocation of rights in technical data, and provides, among other things, that a private party is entitled to restrict the Government's rights to release or disclose privately developed technical data outside the Government. This restriction is implemented in the DFARS as the “limited rights” license, which essentially limits the Government's use of such data only for in-house use and which does not include release to Government support contractors.

Historically, the statutorily based scheme has included only two categorical exceptions to the basic nondisclosure requirements for such privately developed data:

• A “type” exception, in which the Government is granted unlimited rights in certain types of “top-level” data that are not treated as proprietary (e.g., form, fit, and function data; data necessary for operation, maintenance, installation, or training; publicly available data) (2320(a)(2)(C)); and

• A “special needs” exception for certain important Government activities that are considered critical to Government operations (e.g., emergency repair and overhaul; evaluation by a foreign government), and are allowed only when the recipient of the data is made subject to strict nondisclosure restrictions on any further release of the data. (2320(a)(2)(D))

Section 821 amends 10 U.S.C. 2320 to add a third statutory exception to the prohibition on release of privately developed data outside the Government, allowing a covered Government support contractor access to and use of any technical data delivered under a contract for the sole purpose of furnishing independent and impartial advice or technical assistance directly to the Government in support of the Government's management and oversight of the program or effort to which such technical data relates. The statute also provides a definition of “covered Government support contractor.”

Four respondents submitted public comments in response to the interim rule.

II. Discussion and Analysis

DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments are provided as follows:

A. Summary of Significant Changes

1. DoD has revised DFARS 227.7104(b) and the definition of “Small Business Innovation Research (SBIR) data rights” to clarify the Government's limited rights in technical data and restricted rights in computer software under the SBIR data rights license obtained under the clause at 252.227-7018.

2. DoD has deleted the requirement that the covered Government support contractor provide copies of any non-disclosure agreements (NDAs) executed with proprietary information owners, upon request of the Contracting Officer (see 209.505-4, 252.227-7013(b)(3)(iv)(E), 252.227-7014(b)(3)(iii)(E), 252.227-7015(b)(3)(v), 252.227-7018(b)(8)(v), 252.227-7025(b)(1)(ii)(E), and 252.227-7025(b)(4)(ii)(E)). This is not a statutory requirement, and the benefit to the Government in collecting these copies is outweighed by the administrative burden.

Comment:Two respondents suggested that proprietary information should not be disclosed to support contractors until after the owner is given notice an NDA is executed. The respondents stated that if the Government allows access to the proprietary information without an NDA in place, then the proprietary information owner “loses the opportunity to enforce its rights” and the covered Government support contractor would no longer be motivated to enter into an NDA.

DoD Response:A covered Government support contractor may not receive access to proprietary information in the absence of appropriate legally binding non-disclosure obligations. The Government's contract with a covered Government support contractor must always contain the clause at 252.227-7025, which places legally binding use and non-disclosure restrictions on the covered Government support contractor before it has access to any proprietary information. In addition, 252.227-7025(c) expressly confirms that the owner of the proprietary information is a third-party beneficiary of those use and non-disclosure obligations and has a direct cause of action against the covered Government support contractor for any breach of those obligations. Thus, the covered Government support contractor cannot receive any such proprietary information unless and until it is already subject to, at a minimum, the legally binding use and nondisclosure obligations of the clause at 252.227-7025, which also subjects the covered Government support contractor to a direct cause of action by the proprietary information owner.

b. Use and Non-Disclosure Agreement (DFARS 227.7103-7)

Comment:One respondent suggested that in addition to allowing a Contractor to enter an NDA with the covered Government support contractor or towaive its right to an NDA, the contractor should be allowed, alternatively, to require the covered Government support contractor to execute the Use and Non-Disclosure Agreement in 227.7103-7.

DoD Response:The Use and Non-Disclosure Agreement at 227.7103-7 is an agreement between the Government and a private party, and is used only when the information is being provided to the private party outside of a contract that contains the clause at 252.227-7025. When the receiving party is a covered Government support contractor, then, by definition, the contract under which the information is being provided must contain the clause at 252.227-7025—or else the receiving contractor cannot qualify as a covered Government support contractor and would not be authorized to receive the proprietary information for that contract performance. Thus, in these cases, the clause at 252.227-7025 is already applicable and the NDA at 227.7103-7 is not to be used. Moreover, the 227.7103-7 NDA would be insufficient because it does not address the specialized restrictions for covered Government support contractors—because those restrictions are fully implemented in the clause at 252.227-7025, which must be in the contract in order for the recipient to qualify to receive the information as a covered Government support contractor.

c. Non-Disclosure Agreements That Exceed the Terms and Conditions of DFARS 252.227-7025

Comment:Two respondents suggested that the requirement, in the NDA between the contractor and the covered Government support contractor, prohibiting any additional terms and conditions over those present in 252.227-7025 without mutual agreement of the parties, would cause covered Government support contractors to “balk” at signing industry standard NDAs which most often include terms and conditions that are not included in 252.227-7025, and that the restrictions set forth in the clause “do not make a legally sufficient document”. The respondents suggested removing the prohibition by providing language allowing additional terms and conditions.

One respondent also noted that an example of a restriction that is not included in the clause at 252.227-7025 but that is “particularly important for enforcement” of the proprietary information owner's rights, would be a requirement for the covered Government support contractor to have its employees sign individual NDAs containing materially similar terms.

DoD Response:Regarding the legal sufficiency and effect of 252.227-7025, that clause unequivocally establishes a legally sufficient and binding obligation on the recipient of the information, which expressly includes all of the restrictions provided in the statutory language, and which expressly affirms that the proprietary information owner is a third-party beneficiary of those clause obligations and thereby has a direct cause of action against the recipient of the proprietary information for any breach of those obligations. Additionally, the clause at 252.227-7025 requires that any such direct NDA between the covered Government support contractor and the proprietary information owner will “implement” the requirements of the clause at 252.227-7025, which would require, at a minimum, terms and conditions that are necessary to establish a legally sufficient NDA that covers all of the restrictions and obligations contained in the clause at 252.227-7025. Beyond those minimums, the parties are also free to negotiate for any additional terms and conditions by mutual agreement, but neither party can require the other to agree to a term or condition that is outside of those necessary to implement the 252.227-7025 requirements (which fully implement the statutory requirements).

DoD agrees with the respondent's suggestion that it is important to require the covered Government support contractor to ensure that its employees are subject to appropriate non-disclosure obligations, and observes that the obligations on the recipient contractor in the clause at 252.227-7025 do, in fact, create an obligation for that contractor to ensure that it implements the use and nondisclosure restrictions appropriately in the performance of its contractual duties, which would necessarily include ensuring that its employees who will have access or use of the proprietary information are subject to the applicable use and nondisclosure restrictions. However, to the extent that this may be viewed as an implicit obligation of the clause at 252.227-7025, and thus potentially could be overlooked or less than fully understood, such ambiguity must be eliminated. Accordingly, DoD has added a new paragraph (d) to 252.227-7025 to explicitly require the recipient contractor to ensure that its employees are subject to use and non-disclosure obligations prior to the employees being provided access to or use of the proprietary information.

d. Performance Assessments and Root Cause Analysis (PARCA) Activities

Comment:One respondent suggested that DoD's Performance Assessments and Root Cause Analysis (PARCA) activities related to utilizing a “master NDA” between the Government and support contractors to cover third-party proprietary earned value management data (wherein the data owner is a third-party beneficiary of the master NDA) may be inconsistent with the approach in this rule (i.e., which provides for individual “direct” NDAs between the support contractor and the proprietary information owner), and recommends internal DoD coordination to eliminate inconsistencies. The respondent acknowledged that although such earned value management data largely involves “proprietary financial, business, and contract performance data and not Limited Rights Technical Data or Restricted Rights Software, it would be most beneficial to ensure consistency in the processes for disclosing both types of data.”

DoD Response:This rule requires the use of the clause at 252.227-7025 with all covered Government support contractors, which serves as a form of “master NDA” between the Government and the support contractor, in which the proprietary information owner is a third-party beneficiary of that NDA and thereby has a direct cause of action against the support contractor for any breach of the NDA requirements. However, as noted by the respondent, earned value management data does not include limited rights technical data or restricted rights computer software, and thus the PARCA efforts are outside the scope of this rule, as well as the underlying statutory obligations regarding a direct NDA between a covered Government support contractor and the proprietary information owner.

2. Notification Requirements

Comment:One respondent suggested that a covered Government support contractor should be obligated to notify the proprietary information owner upon first access to the proprietary information and annually thereafter.

DoD Response:The interim rule placed a direct obligation on the covered Government support contractor to notify the proprietary information owner upon first access to the proprietary information.

DoD has added at 252.227-7025(b)(5)(iii) a requirement to provide a thirty (30) day period within which the covered Government support contractor must notify the Contractor of the release or disclosure of theContractor's limited rights data to the covered Government support contractor. The thirty (30) day period will provide a reasonable time for notification.

The recommended annual notification requirement would place an onerous administrative burden on the covered Government support contractor. Accordingly, the final rule does not require an annual notification.

3. Use and Release Conditions

Comment:One respondent suggested that the use and release conditions that a covered Government support contractor must agree to, as set forth in 10 U.S.C. 2320 (f)(2)(A)-(E), be added to the definition of “covered Government support contractor” at 252.227-7013(a)(5)(ii), 252.227-7014(a)(6)(ii), 252.227-7015(a)(2)(ii), and 252.227-7018(a)(6)(ii).

DoD Response:These conditions are present in, and applied to all covered Government support contractors, at paragraph (b)(5) of 252.227-7025, which is a required clause for all contracts when it is anticipated that the Government will provide the contractor, for performance of its contract, technical data marked with another contractor's restrictive legend(s) (see clause prescriptions at 227.7103-6 (c), 227.7104(f)(1) and 227.7203-6(d)). A support contractor cannot qualify as a covered Government support contractor unless it meets the definition of a “covered Government support contractor,” which requires that the clause at 252.227-7025 be included in the covered Government support contractor's contract and thereby applies all of the cited restrictions to the covered Government support contractor's use of the relevant data or software to perform that contract. This structure was used to include the substance of the applicable use and release conditions within the clause that serves to apply the restrictions to contractors of any and all types, including covered Government support contractors that are receiving such Government-furnished information (GFI). Thus, these restrictions are included in the definition of “covered Government support contractor” by cross-reference.

4. Access and Use Restrictionsa. Clarification

Comment:One respondent suggested that the rule should clarify the access and use restrictions on a covered Government support contractor by expressly citing the statutory purpose limitation of “for the sole purpose of furnishing independent and impartial advice or technical assistance directly to the Government in support of the Government's management and oversight of the program or effort to which such [proprietary information] relates” in the definitions of “limited rights” and “restricted rights” at DFARS 252.227-7013(a)(14)(i)(B)(1), 252.227-7014(a)(15)(vii), -7018(a)(15)(i)(B)(1), and 252.227-7018(a)(18)(vii), and in the corresponding limitations on the covered Government support contractor's access and use of such information at 252.227-7025(b)(5)(i).

DoD Response:The statutory purpose restrictions on the covered Government support contractor's access and use of such proprietary information are expressly incorporated at 252.227-7025(b)(5)(i) into the access and use restrictions on a covered Government support contractor for limited rights technical data and restricted rights computer software, and also for technical data related to commercial items.

However, DoD has clarified the definitions of “limited rights” and “restricted rights” to specify that the Government's authorized release to a covered Government support contractor is in the performance of a covered Government support contract (which necessarily contains the clause at 252.227-7025). Thus no further revisions are necessary. This structure was used to include the substance of the applicable use and release conditions within the clause that serves to apply the restrictions to the covered Government support contractors.

b. Covered Government Support Contractors' “Access and Use” of Proprietary Data

Comment:One respondent noted that the statute authorizes covered Government support contractors only to “access and use” the third party proprietary data, and suggested the deletion of the additional terms “modify, reproduce, perform, display, release or disclose” (or corresponding terms “modification, reproduction, performance, display, release or disclose”) in several sections of the rule (e.g., 252.227-7013(a)(14)(i)(B)(1), 252.227-7014(a)(15)(vii), 252.227-7018(a)(15)(i)(B)(1) and (a)(18)(vii), and 252.227-7025(b)(4)(ii)(A)).

DoD Response:Independently of the subject matter of this rule, the statutory language at 10 U.S.C. 2320 and 2321 refer to a limited set of regulated activities relating to technical data (e.g., “use” and “release”) However, in the detailed implementation of the statutory scheme, the DFARS utilizes a more complete set of verbs (e.g., “use, modify, reproduce, modify, perform, display, release or disclose”) to ensure that all relevant activities are covered, including recognizing the inherent elements of a generic “use” that are expressly distinguished in the U.S. copyright laws (see, e.g., 17 U.S.C. 106). The rule uses this more complete and detailed set of verbs to be consistent with long-standing conventions in implementing these statutory requirements. In addition, all of the covered activities are subject to the numerous restrictions and safeguards that are implemented to protect the interests of the owner of the proprietary data.

5. Authorized Person

Comment:Two respondents noted that in the definitions of “limited rights” and “restricted rights” the covered Government support contractor is authorized to release the proprietary information to an “authorized person” in performing the covered Government support contractor's contract (see DFARS 252.227-7013(a)(14)(i)(B)(1), 252.227-7014(a)(15)(vii) and 252.227-7018(a)(15)(i)(B)(1)). The respondents suggested that the term “authorized person” be defined to “limit the support contractor's right to release or disclose—to within the support contractor's organization, and only for the performance of the support contract” or “only to the Government, the contractor that owns the proprietary data, or parties the support contractor has confirmed have entered a non-disclosure agreement, license, subcontract, or other agreement giving the owning parties' permission for such disclosure.”

DoD Response:To make the reference to “authorized person” more clear, DoD has replaced the reference to an “authorized person” that was used in the interim rule definitions of “limited rights” and “restricted rights” with the more definitive and accurate phrases “a person authorized to receive limited rights technical data” and “a person authorized to receive restricted rights computer software,” respectively.

6. Definition of “Restricted Rights”

Comment:One respondent noted that the rule makes revisions to the coverage for restricted rights noncommercial computer software that are analogous to the revisions for limited rights technical data, but recommends revisions to recognize certain important differences between restricted rights computer software and limited rights technical data (e.g., that the Government's rights to use and reproduce restricted rights software are proscribed differently andto a greater extent than for limited rights technical data). The respondent recommends revisions to ensure that the covered Government support contractor's authorized use of restricted rights software is subject to all of the restrictions that apply to the Government's use (while retaining the additional restrictions that further restrict the covered Government support contractor's activities).

DoD Response:DoD has revised the definition of “restricted rights” to address the concerns raised by the respondent, ensuring that the covered Government support contractor's authorized uses are no greater than the uses authorized for the Government (see 252.227-7014(a)(15)(v)(D), (vi)(C), and (vii); and 252.227-7018(a)(18)(iv)(B), (v)(D), (vi)(C), and (vii)).

7. Covered Government Support Contractor Organizational Conflict of Interest

Comment:One respondent noted that the rule covers situations in which a covered Government support contractor could be in competition with a contractor-owner of proprietary data by prohibiting the support contractor from using that data to compete for any contracts, but this does not cover a support contractor that may not be considered to be in competition, but that would have access to such proprietary information in the course of advising the Government on overall acquisition strategies. The respondent recommends that the rule be revised to specifically prohibit such a support contractor from using the data to advise the Government on acquisition strategies or overall strategies in way that would benefit the support contractor.

One respondent commented that the interim rule seemed to conflict with DoD guidance regarding organizational conflicts of interest, observing that one part of a large defense contractor might provide Government support contracting services thus creating opportunities for that contractor to obtain proprietary data of competitors. The respondent stated that only in limited circumstances on a case-by-case basis should support contractors be looking at proprietary information from other contractors and noted that a more appropriate solution might be to reduce DoD dependence on contractors.

DoD Response:Independently of this rule, the organizational conflict of interest rules restrict a support contractor, including a covered Government support contractor, from advising the Government on acquisition strategies or overall strategies, or any other matter, in which the support contractor would have a financial or other interest (i.e., that would qualify as an organizational conflict of interest). Those prohibitions and restrictions apply regardless of whether the advising support contractor would have access to any third party proprietary data in the course of such advising. This rule supplements those existing organizational conflict of interest restrictions by adding layers of restriction, and additional safeguards, to ensure that any covered Government support contractor's access to a third party proprietary data does not result in any competitive harm to the third party data owner.

The rule implements the statutory prohibition against covered Government support contractors having affiliations with the prime and first-tier subs, or any direct competitor of the prime or such first-tier sub and reflects the policy determinations inherent in the statute. Alteration of DoD policy regarding the extent of DoD reliance on contractors is beyond the scope of rulemaking for this statutory implementation.

8. Lower-Tier Subcontractor Affiliations

Comment:One respondent commented that the definition of “covered Government support contractor” is limited to preclude affiliation only with the prime and first-tier subcontractors on the relevant program(s), and suggested that support contractors that are not covered by the rule can have affiliations to lower-tier subcontractors and would not be subject to the requirement to sign the direct NDA. The respondent suggested that the rule should be amended to bring such support contractors under the requirement to sign the direct NDA.

DoD Response:The prohibition against covered Government support contractors having affiliations with the prime and first-tier subcontractors is a substantive limitation from the statutory definition of “covered Government support contractor.” Changing the scope of the definition to prohibit affiliations at lower tiers would narrow the scope of the definition of “covered Government support contractor” in a manner that is inconsistent with the statute. The statutory scheme permits affiliations at lower tiers, but established numerous restrictions and protections to ensure that the covered Government support contractor's access to proprietary information does not result in competitive harm. This scheme is reinforced in all cases by the rules and restrictions against organizational conflicts of interest. Thus, a support contractor with affiliations at lower tiers may still qualify as a covered Government support contractor if it meets all other definitional criteria (see 252.227-7013(a)(5), 252.227-7014(a)(6), 252.227-7015(a)(2), and 252.227-7018(a)(6)), but in all such cases the covered Government support contractor would be subject to the obligations regarding direct NDAs (see 252.227-7025(b)(1)(ii)(D), (b)(4)(ii)(D), and (d)). If a support contractor is not covered by the rule (i.e., does not meet the definition of “covered Government support contractor”), then that support contractor would not be subject to that direct NDA requirement, but that is because the support contractor would not be authorized to receive the proprietary information as a covered Government support contractor in the first place. It is impossible under this rule for a covered Government support contractor to be authorized to receive such proprietary information and not to be subject to the obligations regarding direct NDAs.

9. DFARS Coverage at 209.5

Comment:One respondent commented that it was not clear if the language of DFARS 209.505-4(b) of the interim rule was meant to be a replacement or supplement for FAR 9.505-4(b). The respondent also commented that DFARS 209.505-4(b) covers all proprietary information, whereas the revisions to 10 U.S.C. 2320 cover only technical data and the proposed revisions cover both cases.

DoD Response:The DFARS text at 209.505-4(b) addresses DoD-specific requirements and procedures applicable only to third party proprietary technical data and computer software being accessed by DoD contractors, including covered Government support contractors, which provides specific coverage for a subset of the more generic coverage in the FAR. In DoD, the unmodified FAR coverage still applies to DoD contractors accessing other types of proprietary information in the performance of their contracts. The numbering is consistent with DFARS drafting conventions.

10. Commercial Restrictive Legend

Comment:With respect to DFARS 252.227-7025(b)(4)(i), one respondent commented that there is no requirement for a commercial restrictive legend in 10 U.S.C. 2320 or DFARS 252.227-7015, nor is that term defined in the interim rule. The respondent suggested deletion of all references to a commercial restrictive legend.

DoD Response:It is correct that neither 10 U.S.C. 2320 nor DFARS 252.227-7015 provides the specificform, content, or format for a restrictive legend on technical data related to commercial items (or technical data that is a commercial item). However, in accordance with 252.227-7015(d), the Government, and other persons to whom the Government may have released or disclosed technical data delivered or otherwise furnished under a contract, shall have no liability for any release or disclosure of technical data that are not “marked to indicate that such data are licensed data subject to use, modification, reproduction, release, performance, display, or disclosure restrictions.” In addition, although not included as a separate definition in the paragraph (a) definitions section of the clause at 252.227-7025, the reference to “commercial restrictive legend” is defined parenthetically at 252.227-7025(b)(4)(i) as “(i.e., marked to indicate that such data are subject to use, modification, reproduction, release, performance, display, or disclosure restrictions).”

11. Technical Correction

Comment:One respondent commented that in the interim rule, the definitions of “limited rights,” “restricted rights,” and “government purpose rights” were renumbered in DFARS 252.227-7013(a) and 252.227-7014(a), but the renumbering was not accommodated in 252.227-7013(b)(4) and 252.227-7014(b)(4) in an apparent drafting error. This had the effect of making government purpose rights the minimum rights that must be provided to the Government in Specially Negotiated License Rights.

DoD Response:The respondent is correct. DoD issued a technical amendment on February 24, 2012, to correct the text of 252.227-7013(b)(4) and (b)(6), and 252.227-7014(b)(4) and (b)(6) to refer respectively to 252.227-7013(a)(14) (limited rights) and 252.227-7014(a)(15) (restricted rights) (see 77 FR 10976). DoD also corrected paragraph references in 252.227-7013(b)(2)(i)(A).

B. Other changes

1. Conforming changes are made to paragraphs (b)(20), (b)(21), (c)(2) and (c)(3) of the clause at 252.212-7001, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items,” to update the cross-references to the clauses modified by this final rule.

2. 252.227-7025(b)(1)(ii) and 252.227-7025(b)(4)(ii) now reference a new paragraph (b)(5), to avoid repetition of the restrictions in each location. The restrictions regarding GFI marked with limited or restricted rights legends and GFI marked with commercial restrictive legends respectively are revised for clarity.

III. Executive Orders 12866 and 13563

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review by the Office of Information and Regulatory Affairs under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

IV. Regulatory Flexibility Act

DoD has prepared a final regulatory flexibility analysis consistent with 5 U.S.C. 603. A copy of the analysis may be obtained from the point of contact specified herein. The analysis is summarized as follows:

This rule amends the Defense Federal Acquisition Regulation Supplement DFARS) to implement section 821 of the National Defense Authorization Act for Fiscal Year 2010. Section 821 provides authority for certain types of Government support contractors to have access to proprietary technical data belonging to prime contractors and other third parties, provided that the technical data owner may require the support contractor to execute a non-disclosure agreement having certain restrictions and remedies.

No public comments were received in response to the initial regulatory flexibility analysis.

No comments were received from the Chief Counsel for Advocacy of the Small Business Administration in response to the rule. The rule affects small businesses that are Government support contractors that need access to proprietary technical data or computer software belonging to prime contractors and other third parties. It will also affect any small business that is the owner of “limited rights” technical data or restricted rights computer software in the possession of the Government to which the support contractor will require access.

The rule imposes no reporting, recordkeeping, or other information collection requirements. However, the statute provides that the support contractor must be willing to sign a nondisclosure agreement with the owner of the data. The rule has implemented this requirement in a way that preserves maximum flexibility for the private parties to reach mutual agreement without unnecessary interference from the Government. To reduce burdens, the rule permits the owner of the data to waive the requirement for a nondisclosure agreement, since the Government clauses already adequately deal with non-disclosure. Further, the rule provides that the support contractors cannot be required to agree to any conditions not required by statute. In the final rule, DoD has deleted the requirement to provide a copy of the non-disclosure agreement or waiver to the contracting officer, upon request.

Other than the alternatives already addressed, there are no known significant alternatives to the rule that would meet the requirements of the statute and minimize any significant economic impact of the rule on small entities. The impact of this rule on small business is not expected to be significant because the execution of a non-disclosure agreement is not likely to have a significant cost or administrative impact.

V. Paperwork Reduction Act

The rule imposes no new reporting, recordkeeping, or other information collection requirements. DFARS clauses 252.227-7013, 252.227-7014, 252.227-7015, and 252.227-7025 contain reporting or recordkeeping requirements that require the approval of the Office of Management and Budget under 44 U.S.C. chapter 35. However, these clauses are already covered by an approved OMB control number 0704-0369 in the amount of approximately 1.76 million hours.

List of Subjects in 48 CFR Parts 209, 227, and 252

Government procurement.

Kortnee Stewart,Editor, Defense Acquisition Regulations System

Therefore, DoD amends 48 CFR parts 209, 227, and 252 as follows:

1. The authority citation for parts 209 and 252 continues to read as follows:Authority:

41 U.S.C. 1303 and 48 CFR Chapter 1.

PART 209—CONTRACTOR QUALIFICATIONS2. Section 209.505-4 is revised to read as follows:209.505-4Obtaining access to proprietary information.

(b) For contractors accessing third party proprietary technical data or computer software, non-disclosure requirements are addressed at 227.7103-7(b), through use of the clause at 252.227-7025 as prescribed at 227.7103-6(c) and 227.7203-6(d). Pursuant to that clause, covered Government support contractors may be required to enter into non-disclosure agreements directly with the third party asserting restrictions on limited rights technical data, commercial technical data, or restricted rights computer software. The contracting officer is not required to obtain copies of these agreements or to ensure that they are properly executed.

PART 227—PATENTS, DATA, AND COPYRIGHTS3. The authority citation for Part 227 is amended by removing citation “41 U.S.C. 421 and 48 CFR Chapter 1” and adding citation “41 U.S.C. 1303 and 48 CFR Chapter 1” in its place.227.7103-5[Amended]4. Section 227.7103-5 paragraph (c)(2) is amended by inserting a comma after the word “release”.5. Section 227.7104 is amended by revising paragraph (b) and (c) to read as follows:227.7104Contracts under the Small Business Innovation Research (SBIR) Program.

(a) * * *

(b) Under the clause at 252.227-7018, the Government obtains SBIR data rights in technical data and computer software generated under the contract and marked with the SBIR data rights legend. SBIR data rights provide the Government limited rights in such technical data and restricted rights in such computer software during the SBIR data protection period commencing with contract award and ending five years after completion of the project under which the data were generated. Upon expiration of the five-year restrictive license, the Government has unlimited rights in the SBIR technical data and computer software.

(c) During the SBIR data protection period, the Government may not release or disclose SBIR technical data or computer software to any person except as authorized for limited rights technical data or restricted rights computer software, respectively.

PART 252—SOLICITATION PROVISIONS AND CONTRACT CLAUSES252.212-7001[Amended]6. Section 252.212-7001 is amended—a. By removing the clause date “(FEB 2013)” and adding “(MAY 2013)” in its place;b. In paragraph (b)(20), by removing the clause date “(FEB 2012)” and adding “(MAY 2013)” in its place;c. In paragraph (b)(21), by removing the clause date “(DEC 2011)” and adding “(MAY 2013)” in its place;d. In paragraph (c)(2,) by removing the clause date “(FEB 2012)” and adding “(MAY 2013)” in its place; ande. In paragraph (c)(3,) by removing the clause date “(DEC 2011)” and adding “(MAY 2013)” in its place.252.227-7013[Amended]7. Section 252.227-7013 is amended—a. By removing the clause date “(FEB 2012)” and adding “(MAY 2013)” in its place;b. By revising paragraph (a)(14)(i)(B)(1); and (b)(3)(iv) to read as follows:252.227-7013Rights in Technical Data—Noncommercial Items.

(a) * * *

(14) * * *

(i) * * *

(B) A release or disclosure to—

(1) A covered Government support contractor in performance of its covered Government support contract for use, modification, reproduction, performance, display, or release or disclosure to a person authorized to receive limited rights technical data; or

(b) * * *

(3) * * *

(iv) The Contractor acknowledges that—

(A) Limited rights data are authorized to be released or disclosed to covered Government support contractors;

(B) The Contractor will be notified of such release or disclosure;

(C) The Contractor (or the party asserting restrictions as identified in the limited rights legend) may require each such covered Government support contractor to enter into a non-disclosure agreement directly with the Contractor (or the party asserting restrictions) regarding the covered Government support contractor's use of such data, or alternatively, that the Contractor (or party asserting restrictions) may waive in writing the requirement for a non-disclosure agreement; and

(D) Any such non-disclosure agreement shall address the restrictions on the covered Government support contractor's use of the limited rights data as set forth in the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends. The non-disclosure agreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the non-disclosure agreement.

252.227-7014[Amended]8. Section 252.227-7014 is amended—a. By removing the clause date “(FEB 2012)” and adding “(MAY 2013)” in its place;b. By revising paragraph (a)(15); and (a)(16)(b)(iii) to read as follows:252.227-7014Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation.

(i) Use a computer program with one computer at one time. The program may not be accessed by more than one terminal or central processing unit or time shared unless otherwise permitted by this contract;

(ii) Transfer a computer program to another Government agency without the further permission of the Contractor if the transferor destroys all copies of the program and related computer software documentation in its possession and notifies the licensor of the transfer. Transferred programs remain subject to the provisions of this clause;

(iii) Make the minimum number of copies of the computer software required for safekeeping (archive), backup, or modification purposes;

(iv) Modify computer software provided that the Government may—

(A) Use the modified software only as provided in paragraphs (a)(15)(i) and (iii) of this clause; and

(B) Not release or disclose the modified software except as provided in paragraphs (a)(15)(ii), (v), (vi) and (vii) of this clause;

(v) Permit contractors or subcontractors performing service contracts (see 37.101 of the Federal Acquisition Regulation) in support ofthis or a related contract to use computer software to diagnose and correct deficiencies in a computer program, to modify computer software to enable a computer program to be combined with, adapted to, or merged with other computer programs or when necessary to respond to urgent tactical situations, provided that—

(A) The Government notifies the party which has granted restricted rights that a release or disclosure to particular contractors or subcontractors was made;

(B) Such contractors or subcontractors are subject to the use and non-disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement (DFARS) or are Government contractors receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends;

(C) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(D) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause;

(vi) Permit contractors or subcontractors performing emergency repairs or overhaul of items or components of items procured under this or a related contract to use the computer software when necessary to perform the repairs or overhaul, or to modify the computer software to reflect the repairs or overhaul made, provided that—

(A) The intended recipient is subject to the use and non-disclosure agreement at DFARS 227.7103-7 or is a Government contractor receiving access to the software for performance of a Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends;

(B) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(C) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iii) of this clause; and

(vii) Permit covered Government support contractors in the performance of covered Government support contracts that contain the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends, to use, modify, reproduce, perform, display, or release or disclose the computer software to a person authorized to receive restricted rights computer software, provided that—

(A) The Government shall not permit the covered Government support contractor to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(15)(iv) of this clause, for any other purpose; and

(B) Such use is subject to the limitations in paragraphs (a)(15)(i) through (iv) of this clause.

(16) * * *

(b) * * *

(3) * * *

(iii) The Contractor acknowledges that—

(A) Restricted rights computer software is authorized to be released or disclosed to covered Government support contractors;

(B) The Contractor will be notified of such release or disclosure;

(C) The Contractor (or the party asserting restrictions, as identified in the restricted rights legend) may require each such covered Government support contractor to enter into a non-disclosure agreement directly with the Contractor (or the party asserting restrictions) regarding the covered Government support contractor's use of such software, or alternatively, that the Contractor (or party asserting restrictions) may waive in writing the requirement for a non-disclosure agreement; and

(D) Any such non-disclosure agreement shall address the restrictions on the covered Government support contractor's use of the restricted rights software as set forth in the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends. The non-disclosure agreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the non-disclosure agreement.

9. Section 252.227-7015 is amended—a. By removing the clause date “(DEC 2011)” and adding “(MAY 2013)” in its place;b. By revising paragraph (b)(3) to read as follows:252.227-7015Technical Data—Commercial Items.

(b) * * *

(3) The Contractor acknowledges that—

(i) Technical data covered by paragraph (b)(2) of this clause are authorized to be released or disclosed to covered Government support contractors;

(ii) The Contractor will be notified of such release or disclosure;

(iii) The Contractor (or the party asserting restrictions as identified in a restrictive legend) may require each such covered Government support contractor to enter into a non-disclosure agreement directly with the Contractor (or the party asserting restrictions) regarding the covered Government support contractor's use of such data, or alternatively, that the Contractor (or party asserting restrictions) may waive in writing the requirement for annon-disclosure agreement; and

(iv) Any such non-disclosure agreement shall address the restrictions on the covered Government support contractor's use of the data as set forth in the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends. The non-disclosure agreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the non-disclosure agreement.

10. Section 252.227-7018 is amended—a. By removing the clause date “(MAR 2011)” and adding “(MAY 2013)” in its place;b. By revising paragraphs (a)(15); (a)(18); (a)(19); (b)(4); (b)(5); and (b)(8) to read as follows:252.227-7018Rights in Noncommercial Technical Data and Computer Software—Small Business Innovation Research (SBIR) Program.

(a) * * *

(15) “Limited rights” means the rights to use, modify, reproduce, release, perform, display, or disclose technical data, in whole or in part, within the Government. The Government may not, without the written permission of the party asserting limited rights, release or disclose the technical data outside the Government, use the technical data for manufacture, or authorize the technical data to be used by another party, except that the Government may reproduce, release, or disclose such data or authorize the use or reproduction of the data by persons outside the Government if—

(i) The reproduction, release, disclosure, or use is—

(A) Necessary for emergency repair and overhaul; or

(B) A release or disclosure to—

(1) A covered Government support contractor in performance of its covered Government support contracts for use, modification, reproduction, performance, display, or release or disclosure to a person authorized to receive limited rights technical data; or

(2) A foreign government, of technical data other than detailed manufacturing or process data, when use of such data by the foreign government is in the interest of the Government and is required for evaluational or informational purposes;

(ii) The recipient of the technical data is subject to a prohibition on the further reproduction, release, disclosure, or use of the technical data; and

(iii) The contractor or subcontractor asserting the restriction is notified of such reproduction, release, disclosure, or use.

(i) Use a computer program with one computer at one time. The program may not be accessed by more than one terminal or central processing unit or time shared unless otherwise permitted by this contract;

(ii) Transfer a computer program to another Government agency without the further permission of the Contractor if the transferor destroys all copies of the program and related computer software documentation in its possession and notifies the licensor of the transfer. Transferred programs remain subject to the provisions of this clause;

(iii) Make the minimum number of copies of the computer software required for safekeeping (archive), backup, or modification purposes;

(iv) Modify computer software provided that the Government may—

(A) Use the modified software only as provided in paragraphs (a)(18)(i) and (iii) of this clause; and

(B) Not release or disclose the modified software except as provided in paragraphs (a)(18)(ii), (v), (vi), and (vii) of this clause;

(v) Permit contractors or subcontractors performing service contracts (see 37.101 of the Federal Acquisition Regulation) in support of this or a related contract to use computer software to diagnose and correct deficiencies in a computer program, to modify computer software to enable a computer program to be combined with, adapted to, or merged with other computer programs or when necessary to respond to urgent tactical situations, provided that—

(A) The Government notifies the party which has granted restricted rights that a release or disclosure to particular contractors or subcontractors was made;

(B) Such contractors or subcontractors are subject to the non-disclosure agreement at 227.7103-7 of the Defense Federal Acquisition Regulation Supplement or are Government contractors receiving access to the software for performance of a Government contract that contains the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends;

(C) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(18)(iv) of this clause, for any other purpose; and

(D) Such use is subject to the limitations in paragraphs (a)(18)(i) through (iii) of this clause;

(vi) Permit contractors or subcontractors performing emergency repairs or overhaul of items or components of items procured under this or a related contract to use the computer software when necessary to perform the repairs or overhaul, or to modify the computer software to reflect the repairs or overhaul made, provided that—

(A) The intended recipient is subject to the non-disclosure agreement at 227.7103-7 or is a Government contractor receiving access to the software for performance of a Government contract that contains the clause at 252.227-7025, Limitations on the Use or Disclosure of Government Furnished Information Marked with Restrictive Legends;

(B) The Government shall not permit the recipient to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(18)(iv) of this clause, for any other purpose; and

(C) Such use is subject to the limitations in paragraphs (a)(18)(i) through (iii) of this clause; and

(vii) Permit covered Government support contractors in the performance of Government contracts that contain the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends, to use, modify, reproduce, perform, display, or release or disclose the computer software to a person authorized to receive restricted rights computer software, provided that—

(A) The Government shall not permit the covered Government support contractor to decompile, disassemble, or reverse engineer the software, or use software decompiled, disassembled, or reverse engineered by the Government pursuant to paragraph (a)(18)(iv) of this clause, for any other purpose; and

(B) Such use is subject to the limitations in paragraphs (a)(18)(i) through (iv) of this clause.

(4)SBIR data rights.Except for technical data, including computer software documentation, or computer software in which the Government has unlimited rights under paragraph (b)(1) of this clause, the Government shall have SBIR data rights in all technical data or computer software generated under this contract during the period commencing with contract award and ending upon the date five years after completion of the project from which such data were generated.

(5) Specifically negotiated license rights. The standard license rights granted to the Government under paragraphs (b)(1) through (b)(4) of this clause may be modified by mutual agreement to provide such rights as the parties consider appropriate but shall not provide the Government lesser rights in technical data, including computer software documentation, than are enumerated in paragraph (a)(15) of this clause or lesser rights in computer software than are enumerated in paragraph (a)(18) of this clause. Any rights so negotiated shall be identified in a license agreement made part of this contract.

(i) Limited rights technical data and restricted rights computer software are authorized to be released or disclosed to covered Government support contractors;

(ii) The Contractor will be notified of such release or disclosure;

(iii) The Contractor may require each such covered Government support contractor to enter into a non-disclosure agreement directly with the Contractor (or the party asserting restrictions as identified in a restrictive legend) regarding the covered Government support contractor's use of such data or software, or alternatively that the Contractor (or party asserting restrictions) may waive in writing the requirement for a non-disclosure agreement; and

(iv) Any such non-disclosure agreement shall address the restrictions on the covered Government support contractor's use of the data or software as set forth in the clause at 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends. The non-disclosure agreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the non-disclosure agreement.

252.227-7025[Amended]11. Section 252.227-7025 is revised as follows:252.227-7025Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends.

As prescribed in 227.7103-6(c), 227.7104(f)(1), or 227.7203-6(d), use the following clause:

Limitations on the Use or Disclosure of Government-Furnished Information Marked With Restrictive Legends (May 2013)

(a)(1) For contracts in which the Government will furnish the Contractor with technical data, the terms “covered Government support contractor,” “limited rights,” and “Government purpose rights” are defined in the clause at 252.227-7013, Rights in Technical Data-Noncommercial Items.

(2) For contracts in which the Government will furnish the Contractor with computer software or computer software documentation, the terms “covered Government support contractor,” “government purpose rights,” and “restricted rights” are defined in the clause at 252.227-7014, Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation.

(3) For Small Business Innovation Research program contracts, the terms “covered Government support contractor,” “limited rights,” “restricted rights,” and “SBIR data rights” are defined in the clause at 252.227-7018, Rights in Noncommercial Technical Data and Computer Software—Small Business Innovation Research (SBIR) Program.

(b) Technical data or computer software provided to the Contractor as Government-furnished information (GFI) under this contract may be subject to restrictions on use, modification, reproduction, release, performance, display, or further disclosure.

(i) The Contractor shall use, modify, reproduce, perform, or display technical data received from the Government with limited rights legends, computer software received with restricted rights legends, or SBIR technical data or computer software received with SBIR data rights legends (during the SBIR data protection period) only in the performance of this contract. The Contractor shall not, without the express written permission of the party whose name appears in the legend, release or disclose such data or software to any unauthorized person.

(ii) If the Contractor is a covered Government support contractor, the Contractor is also subject to the additional terms and conditions at paragraph (b)(5) of this clause

(2)GFI marked with government purpose rights legends.The Contractor shall use technical data or computer software received from the Government with government purpose rights legends for government purposes only. The Contractor shall not, without the express written permission of the party whose name appears in the restrictive legend, use, modify, reproduce, release, perform, or display such data or software for any commercial purpose or disclose such data or software to a person other than its subcontractors, suppliers, or prospective subcontractors or suppliers, who require the data or software to submit offers for, or perform, contracts under this contract. Prior to disclosing the data or software, the Contractor shall require the persons to whom disclosure will be made to complete and sign the non-disclosure agreement at 227.7103-7.

(3)GFI marked with specially negotiated license rights legends.

(i) The Contractor shall use, modify, reproduce, release, perform, or display technical data or computer software received from the Government with specially negotiated license legends only as permitted in the license. Such data or software may not be released or disclosed to other persons unless permitted by the license and, prior to release or disclosure, the intended recipient has completed the non-disclosure agreement at 227.7103-7. The Contractor shall modify paragraph (1)(c) of the non-disclosure agreement to reflect the recipient's obligations regarding use, modification, reproduction, release, performance, display, and disclosure of the data or software.

(ii) If the Contractor is a covered Government support contractor, the Contractor may also be subject to some or all of the additional terms and conditions at paragraph (b)(5) of this clause, to the extent such terms and conditions are required by the specially negotiated license.

(4)GFI technical data marked with commercial restrictive legends.

(i) The Contractor shall use, modify, reproduce, perform, or display technical data that is or pertains to a commercial item and is received from the Government with a commercial restrictive legend (i.e., marked to indicate that such data are subject to use, modification, reproduction, release, performance, display, or disclosure restrictions) only in the performance of this contract. The Contractor shall not, without the express written permission of the party whose name appears in the legend, use the technical data to manufacture additional quantities of the commercial items, or release or disclose such data to any unauthorized person.

(ii) If the Contractor is a covered Government support contractor, the Contractor is also subject to the additional terms and conditions at paragraph (b)(5) of this clause

(5)Covered Government support contractors.If the Contractor is a covered Government support contractor receiving technical data or computer software marked with restrictive legends pursuant to paragraphs (b)(1)(ii), (b)(3)(ii), or (b)(4)(ii) of this clause, the Contractor further agrees and acknowledges that—

(i) The technical data or computer software will be accessed and used for the sole purpose of furnishing independent and impartial advice or technical assistance directly to the Government in support of the Government's management and oversight of the program or effort to which such technical data or computer software relates, as stated in this contract, and shall not be used to compete for any Government or non-Government contract;

(ii) The Contractor will take all reasonable steps to protect the technical data or computer software against any unauthorized release or disclosure;

(iii) The Contractor will ensure that the party whose name appears in the legend is notified of the access or use within thirty (30) days of the Contractor's access or use of such data or software;

(iv) The Contractor will enter into a non-disclosure agreement with the party whose name appears in the legend, if required to do so by that party, and that any such non-disclosure agreement will implement the restrictions on the Contractor's use of such data or software as set forth in this clause. The non-disclosure agreement shall not include any additional terms and conditions unless mutually agreed to by the parties to the non-disclosure agreement; and

(v) That a breach of these obligations or restrictions may subject the Contractor to—

(A) Criminal, civil, administrative, and contractual actions in law and equity for penalties, damages, and other appropriate remedies by the United States; and

(B) Civil actions for damages and other appropriate remedies by the party whose name appears in the legend.

(c)Indemnification and creation of third party beneficiary rights.The Contractor agrees—

(1) To indemnify and hold harmless the Government, its agents, and employees from every claim or liability, including attorneys fees, court costs, and expenses, arising out of, or in any way related to, the misuse or unauthorized modification, reproduction, release, performance, display, or disclosureof technical data or computer software received from the Government with restrictive legends by the Contractor or any person to whom the Contractor has released or disclosed such data or software; and

(2) That the party whose name appears on the restrictive legend, in addition to any other rights it may have, is a third party beneficiary who has the right of direct action against the Contractor, or any person to whom the Contractor has released or disclosed such data or software, for the unauthorized duplication, release, or disclosure of technical data or computer software subject to restrictive legends.

(d) The Contractor shall ensure that its employees are subject to use and non-disclosure obligations consistent with this clause prior to the employees being provided access to or use of any GFI covered by this clause.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA is 296 metric tons as established by the final 2013 and 2014 harvest specifications for groundfish of the GOA (78 FR 13162, February 26, 2013), for the period 1200 hours, A.l.t., April 1, 2013, through 1200 hours, A.l.t., July 1, 2013.

In accordance with § 679.21(d)(7)(i), the Administrator, Alaska Region, NMFS, has determined that the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species fishery by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

Classification

This action responds to the best available information recently obtained from the fishery. The Acting Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of May 16, 2013.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.

We propose to adopt a new airworthiness directive (AD) for all Eclipse Aerospace, Inc. Model EA500 airplanes equipped with Avio, Avio with ETT, or Avio NG 1.0 avionics suites. This proposed AD was prompted by a report of potential aircraft hardware failure in the autopilot control panel and the center switch panel. This proposed AD would require either incorporating updates to the aircraft computer system or incorporating a temporary revision to the aircraft flight manual. We are proposing this AD to correct the unsafe condition on these products.

DATES:

We must receive comments on this proposed AD by July 8, 2013.

ADDRESSES:

You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

For service information identified in this proposed AD, contact Eclipse Aerospace, Inc. 26 East Palatine Road, Wheeling, Illinois 60090; telephone: (877) 373-7978; Internet:www.eclipse.aero.You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

Examining the AD Docket

You may examine the AD docket on the Internet athttp://www.regulations.gov;or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in theADDRESSESsection. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2013-0448; Directorate Identifier 2013-CE-007-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, tohttp://www.regulations.gov,including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

We have received a report from Eclipse Aviation, Inc. that there is a potential problem with the hardware/software combination within the autopilot control panel and/or center switch panel on all Model EA500 airplanes equipped with Avio, Avio with ETT, or Avio NG 1.0 avionics suites that could result in uncommanded fire suppression system activation and simultaneous shutdown of both engines.

This condition, if not corrected, could cause dual engine failure and result in loss of control.

Relevant Service Information

We reviewed Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-014, Rev. A, dated February 15, 2011, and Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-019, Rev B, dated March 13, 2013. These service bulletins describe procedures for updating the aircraft computer system for all affected airplanes. We have also reviewed Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-026, Rev. A, dated November 6, 2012. This service bulletin described procedures for updating the aircraft flight manual (AFM) for affected airplanes equipped with NG 1.0 avionics suites.

FAA's Determination

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

Proposed AD Requirements

This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and the Service Information.”

Differences Between the Proposed AD and the Service Information

Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-026, Rev. A, dated November 6, 2012, which applies only to airplanes equipped with NG 1.0 avionics suites, requires incorporating a temporary revision into the AFM and incorporating an update to the aircraft computer system (ACS) hardware with monthly data uploads to Eclipse Aerospace, Inc. until the ACS software is updated.Specifically, the AFM revision requires an altered engine start and emergency procedures checklist.

This proposed AD would allow doing either the AFM revision or the ACS software update.

Costs of Compliance

We estimate that this proposed AD affects 81 airplanes of U.S. registry. There are 38 of the affected airplanes equipped with Avio or Avio ETT avionics suites and 43 of the affected airplanes equipped with NG 1.0 avionics suites.

We estimate the following costs to comply with this proposed AD. Airplanes equipped with NG 1.0 avionics suites would be allowed do either the AFM update or the ACS update:

Incorporating the flight manual update represents a terminating action for AD compliance without imposing any limitations on aircraft operations. It is the operator's choice to incorporate either the flight manual update or the software update.

Authority for this Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This AD was prompted by a report of potential aircraft hardware failure in the autopilot control panel and the center switch panel. We are issuing this AD to prevent failure of the hardware/software combination within the autopilot control panel and/or center switch panel, which could result in uncommanded fire suppression system activation and simultaneous shutdown of both engines.

(f) Compliance

Comply with this AD within the compliance times specified, unless already done.

(g) Update Aircraft Computer Software (ACS)

(1)For airplanes equipped with Avio or Avio with ETT avionics suites:Within 6 calendar months after the effective date of this AD, update the ACS following paragraphs 3.A. through 3.C. of the Accomplishment Instructions in Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-014, Rev. A, dated February 15, 2011.

(2)For airplanes equipped with NG 1.0 avionics suites:Within 6 calendar months after the effective date of this AD, do one of the following:

(ii) Update the ACS following paragraphs 3.A. through 3.C. of the Accomplishment Instructions in Eclipse Aerospace, Inc. Mandatory Service Bulletin Number SB 500-31-019, Rev. B, dated March 13, 2013.

(h) Alternative Methods of Compliance (AMOCs)

(1) The Manager, Chicago ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD.

(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(2) For service information identified in this AD, contact Eclipse Aerospace, Inc., 26 East Palatine Road, Wheeling, Illinois 60090; telephone: (877) 373-7978; Internet:www.eclipse.aero.You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

Under section 215 of the Federal Power Act, the Federal Energy Regulatory Commission (Commission) proposes to remand the proposed interpretation of Reliability Standard BAL-002-1, Disturbance Control Performance, Requirements R4 and R5, submitted to the Commission for approval by the North American Electric Reliability Corporation, the Commission-certified Electric Reliability Organization. Specifically, the interpretation addresses whether Balancing Authorities and Reserve Sharing Groups are subject to enforcement actions for failing to restore Area Control Error within the 15-minute Disturbance Recovery Period for Reportable Disturbances that exceed the most severe single Contingency. The Commission proposes to remand the proposed interpretation because it changes a requirement of the Reliability Standard, thereby exceeding the permissible scope for interpretations.

DATES:

Comments are due July 8, 2013.

ADDRESSES:

You may submit comments, identified by docket number by any of the following methods:

•Agency Web site: http://ferc.gov.Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format.

•Mail/Hand Delivery:Commenters unable to file comments electronically must mail or hand deliver an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.

1. Under section 215 of the Federal Power Act (FPA), the Commission proposes to remand the proposed interpretation of Reliability Standard BAL-002-1, Disturbance Control Performance, Requirements R4 and R5 submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization (ERO). Specifically, the interpretation addresses whether Balancing Authorities and Reserve Sharing Groups are subject to compliance enforcement actions for failing to restore Area Control Error (ACE) within the 15-minute Disturbance Recovery Period for Reportable Disturbances that exceed the most severe single Contingency (MSSC). For the reasons explained below, the Commission proposes to remand the proposed interpretation because it changes the requirements of the Reliability Standard, thereby exceeding the permissible scope for interpretations. The Commission seeks comments on its proposal.

I. BackgroundA. Section 215 of the FPA and Standards Development Process

2. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. Specifically, the Commission may approve, by rule or order, a proposed Reliability Standard or modification to a Reliability Standard if it determines that the Standard is just, reasonable, not unduly discriminatory or preferential, and in the publicinterest.1Once approved, the Reliability Standards may be enforced by the ERO, subject to Commission oversight, or by the Commission independently.2Pursuant to section 215 of the FPA, the Commission established a process to select and certify an ERO,3and subsequently certified NERC.4

3. In March 2007, the Commission issued Order No. 693, evaluating 107 Reliability Standards, including the Disturbance Control Performance (BAL-002-0) Reliability Standard.5In Order No. 693, the Commission approved BAL-002-0. In addition, pursuant to section 215(d)(5) of the FPA, the Commission directed the ERO to develop a modification to BAL-002-0 through the Reliability Standards development process that: (1) Includes a Requirement that explicitly provides that Demand Side Management may be used as a resource for contingency reserves; (2) develops a continent-wide contingency reserve policy; and (3) refers to the ERO rather than the NERC Operating Committee in Requirements R4.2 and R6.2.6On January 10, 2011, the Commission approved BAL-002-1 via letter order,7which addressed the third directive described above.

4. NERC's Rules of Procedure provide that all persons “directly and materially affected” by Bulk-Power System reliability may request an interpretation of a Reliability Standard.8In response, the ERO will assemble a team with relevant expertise to address the requested interpretation and also form a ballot pool. NERC's Rules of Procedure provide that, within 45 days, the team will draft an interpretation of the Reliability Standard and submit it to the ballot pool. If approved by the ballot pool and subsequently by the NERC Board of Trustees (Board), the interpretation is appended to the Reliability Standard and filed with the applicable regulatory authorities for approval.

5. Further, NERC's Rules of Procedure state that “[a] valid interpretation response provides additional clarity about one or more Requirements, but does not expand on any Requirement and does not explain how to comply with any Requirement.”9

9Id.at 27.

B. Reliability Standard BAL-002-1

6. The stated purpose of BAL-002-1 is to “ensure the Balancing Authority is able to utilize its Contingency Reserve to balance resources and demand and return Interconnection frequency within defined limits following a Reportable Disturbance.” TheNERC Glossary of Terms Used in Reliability Standards(Glossary) defines Reportable Disturbance as “[A]ny event that causes an ACE change greater than or equal to 80% of a Balancing Authority's or Reserve Sharing Group's most severe contingency.”10

10NERC Glossary at 56. NERC defines Area Control Error or “ACE” as “the instantaneous difference between net actual and scheduled interchange, taking into account the effects of Frequency Bias including correction for meter error.”Id.at 5.

7. Reliability Standard BAL-002-1 has six Requirements. Most relevant to the proposed interpretation, Requirements R3 and R4 provide:

R3. Each Balancing Authority or Reserve Sharing Group shall activate sufficient Contingency Reserve to comply with the DCS.

R3.1. As a minimum, the Balancing Authority or Reserve Sharing Group shall carry at least enough Contingency Reserve to cover the most severe single contingency. All Balancing Authorities and Reserve Sharing Groups shall review, no less frequently than annually, their probable contingencies to determine their prospective most severe single contingencies.

R4. A Balancing Authority or Reserve Sharing Group shall meet the Disturbance Recovery Criterion within the Disturbance Recovery Period for 100% of Reportable Disturbances. The Disturbance Recovery Criterion is:

R4.1. A Balancing Authority shall return its ACE to zero if its ACE just prior to the Reportable Disturbance was positive or equal to zero. For negative initial ACE values just prior to the Disturbance, the Balancing Authority shall return ACE to its pre-Disturbance value.

R4.2. The default Disturbance Recovery Period is 15 minutes after the start of a Reportable Disturbance.

Also relevant to the proceeding is the Additional Compliance Information language in Part D of BAL-002-1, which includes:

Reportable Disturbances—Reportable Disturbances are contingencies that are greater than or equal to 80% of the most severe single Contingency . . .

Simultaneous Contingencies—Multiple Contingencies occurring within one minute or less of each other shall be treated as a single Contingency. If the combined magnitude of the multiple Contingencies exceeds the most severe single Contingency, the loss shall be reported, but excluded from compliance evaluation.

II. NERC's Proposed Interpretation of BAL-002-1 (R4 and R5)

8. On February 12, 2013, NERC filed a petition (Petition) seeking approval of the proposed interpretation of BAL-002-1, developed in response to an interpretation request submitted on September 2, 2009 by the Northwest Power Pool Reserve Sharing Group (NWPP). NERC explains that NWPP requested clarification on the following matters:

(1) although a Disturbance that exceeds the most severe single Contingency must be reported by the Balancing Authority or Reserve Sharing Group (as applicable), is the Disturbance excluded from compliance evaluation for the applicable Balancing Authority or Reserve Sharing Group;

(2) with respect to either simultaneous Contingencies or non-simultaneousmultiple Contingencies affecting a Reserve Sharing Group, the exclusion fromcompliance evaluation for Disturbances exceeding the most severe singleContingency applies both when

(a) all Contingencies occur within a single Balancing Authority member of the Reserve Sharing Group, and

(b) different Balancing Authorities within the Reserve Sharing Group experience separate Contingencies that occur simultaneously, or non-simultaneously but before the end of the Disturbance Recovery Period following the first Reportable Disturbance; and

(3) the meaning of the phrase “excluded from compliance evaluation” as used in Section 1.4 (“Additional Compliance Information”) of Part D of BAL-002-0 and for purposes of the preceding statements is that, with respect to Disturbances that exceed the most severe single Contingency for a Balancing Authority or Reserve Sharing Group (as applicable), a violation of BAL-002-0 does not occur even if ACE is not recovered within the Disturbance Recovery Period (15 minutes unless adjusted pursuant to BAL-002-0, R4.2).11

11NERC Petition at 7.

9. A proposed interpretation was first balloted in February 2010, but failed to achieve a two-third approval from the ballot body.12NERC staff determinedthat any further interpretation could not be developed unless the team could consider the measures and the additional compliance elements of the standard.13In January 2012 NERC staff told the NWPP their interpretation request was “ineligible” under the existing rules for developing interpretations.14

12NERC Petition, Exh. C (Summary of the Interpretation Development Proceedings and Record of Development of Proposed Interpretation) at 1-2.

13Id.at 2. A November 2009 Resolution of the NERC Board that pertained to interpretations included the following passage: “[i]n deciding whether or not to approve a proposed interpretation, the board will use a standard of strict construction and not seek to expand the reach of the standard to correct a perceived gap or deficiency in the standard.”

14NERC Petition, Exh. C at 3.

10. ISO/RTO Council appealed this decision, challenging the BAL-002-1 interpretation process. In a March 2012 letter responding to ISO/RTO Council, NERC staff stated: “Given the difficulty in interpreting the existing language of the standard, NERC recommends to the [ISO/RTO Council] and NWPP that they consider developing and submitting a Standard Authorization Request (SAR) to the Standards Committee to address their concern.”15

15NERC Petition, Exh. C at 3.

11. At its May 2012 meeting, the NERC Board Standards Oversight and Technology Committee (SOTC) concluded that “strict construction for the purposes of interpretation was never meant to limit the materials considered in developing the interpretation solely to the contents of the requirements in a standard, but can include any language in the standard, including compliance related sections.”16The NERC Standards Committee assembled another drafting team that developed a proposed interpretation that received a 90.34 percent approval vote in October 2012. On November 7, 2012, the NERC BOT adopted the proposed interpretation of BAL-002-1.

16Id.

12. In its Petition, NERC states that, in response to NWPP's first question, the proposed interpretation clarifies that Balancing Authorities and Reserve Sharing Groups are not subject to the 15-minute Disturbance Recovery Period for Disturbances that exceed the MSSC.

13. With regard to the second question, NERC explained that the proposed interpretation provides that:

[t]he standard was written to provide pre-acknowledged RSG's the same considerations as a single BA for purposes of exclusions from DCS compliance evaluation . . . [T]his applies to both multiple contingencies occurring within one minute or less of each other being treated as a single Contingency or Contingencies that occur after one minute of the start of a Reportable Disturbance but before the end of the Disturbance Recovery Period.

The standard, while recognizing dynamically allocated RSGs, does NOT provide the members of dynamically allocated RSGs exclusions from DCS compliance evaluation on an RSG basis. For members of dynamically allocated RSGs, the exclusions are provided only on a member BA by member BA basis.17

17Id.at 14-15

14. In response to NWPP's third question regarding the exclusion language in the Additional Compliance Information provision of the standard, the drafting team responded:

The Additional Compliance Information section clearly states: “Simultaneous contingencies—Multiple contingencies occurring within one minute or less of each other shall be treated as a single Contingency. If the combined magnitude of the multiple Contingencies exceeds the Most Severe Single Contingency, the loss shall be reported, but excluded from compliance evaluation.”

Although Requirement R3 does mandate that a BA or RSG activate sufficient Contingency Reserves to comply with DCS for every Reportable Disturbance, there is no requirement to comply with or even report disturbances that are below the Reportable Disturbance level. The averaging obligation does incent calculation and reporting of such lesser events. If a Balancing Authority were to experience a Disturbance five times greater than its most severe single Contingency, it would be required to report this Disturbance, but would not be required to recover ACE within 15 minutes following a Disturbance of this magnitude.

An excludable disturbance is a disturbance whose magnitude was greater than the magnitude of the most severe single contingency. Any other proposed interpretation would result in treating BAL-002-0 as if it required Balancing Authorities and Reserve Sharing Groups to recover ACE (to zero or pre-Disturbance levels, as applicable) within the 15-minute Disturbance Recovery Period without regard to Disturbance magnitude. This is inconsistent with (a) the reserve requirement specified in R3.1 of BAL-002-0, (b) the text of Section 1.4 of Part D of BAL-002-0, and (c) the documented history of the development ofBAL-002-0 . . .18

18NERC Petition at 16.

15. NERC contends that BAL-002-1 is intended to be read as “an integrated whole” and therefore uses the phrase “excluded from compliance evaluation” that appears in Part D, Section 1.5 (“Additional Compliance Information”) as support for concluding that the 15-minute Disturbance Recovery Period contained in Requirement R4 of BAL-002-1 does not apply to Disturbances that exceed the MSSC.19

19NERC Petition at 10-11.

16. NERC asserts that “the proposed interpretation is necessary to prevent Registered Entities from shedding load to avoid possible violations of BAL-002, a result that is inconsistent with reliability principles.”20NERC further asserts that “[i]f the Reliability Standard is interpreted to require that ACE be returned to zero even for a Disturbance that exceeds the most severe single Contingency, a Balancing Authority could be required to take drastic operational actions, even when other measures of system reliability (voltage stability, normal frequency, operation within system operating limits, etc.) indicate otherwise.” NERC adds that “a lack of clarity on the interpretation of [BAL-002] potentially has significant financial and operational impacts on all Balancing Authorities and Reserve Sharing Groups.”21

20Id. at 3.

21Id.at 12.

17. NERC asserts that the proposed interpretation “neither expands on any Requirement nor explains how to comply with a Requirement.”22NERC acknowledges that the proposed interpretation differs from the PacifiCorp Stipulation and Consent Agreement, in which NERC staff and Commission staff determined that PacifiCorp violated BAL-002-0 Requirement R4 by failing to restore its ACE within the 15-minute Disturbance Recovery Period, despite a Disturbance exceeding PacifiCorp's MSSC.23

18. We propose to remand NERC's interpretation of BAL-002-1 because it fails to comport with the Commission-approved requirement that interpretations can only clarify, not change, a Reliability Standard.24Rather, changes to a Reliability Standard must be developed through NERC's standards development procedure as prescribed in NERC's Rules of Procedure.25As discussed below, NERC's proposed interpretation changes Requirement R4 of BAL-002-1 from its plain meaning, and also effectively redefines the term Reportable Disturbance as defined in the NERC Glossary and used in BAL-002-1.

19. NERC's proposal interprets the phrase “excluded from complianceevaluation,” the exclusion language in Part D (Additional Compliance Information), Section 1.5 of BAL-002-1 as limiting the obligation to restore ACE set forth in Requirement R4 of BAL-002-1. As a result, while Requirement R4 of BAL-002-1 provides that a Balancing Authority or Reserve Sharing Group “shall meet the Disturbance Recovery Criterion within the Disturbance Recovery Period [i.e., 15 minutes] for 100 percent of Reportable Disturbances,” the NERC interpretation limits Requirement R4 as applicable to onlysomeReportable Disturbances.

20. Stated differently, while the term “Reportable Disturbance” is defined by NERC as “contingencies that are greater than or equal to 80% of the most severe single contingency,” the NERC interpretation changes the term to mean contingencies that are greater than or equal to 80 percent of the most severe single contingency but no greater than 100 percent of the most severe single contingency.26In sum, the proposed interpretation would relieve a Balancing Authority or Reserve Sharing Group from having to restore ACE within 15 minutes of Disturbances that are greater than 100 percent of the most single severe Contingency, notwithstanding that BAL-002-1 Requirement R4 requires that: “[A] Balancing Authority or Reserve Sharing Group shall meet the Disturbance Recovery Criterion within the Disturbance Recovery Period for 100% of Reportable Disturbances.” Thus, NERC's proposal goes beyond interpreting and, instead, changes a requirement of the Reliability Standard.

26Reliability Standard BAL-002-1, Section D. Compliance, 1.5 (Additional Compliance Information) defines “Reportable Disturbance” as “contingencies that are greater than or equal to 80% of the most severe single contingency.” The definition of “Reportable Disturbance” in the NERC Glossary is “[A]ny event that causes an ACE change greater than or equal to 80% of a Balancing Authority's or reserve sharing group's most severe contingency.” NERC's proposed interpretation is incompatible with both definitions.

21. As mentioned above, NERC's proposed interpretation focuses on the following provision in Part D, Section 1.5 (“Additional Compliance Information”) of BAL-002-1:

Simultaneous Contingencies—Multiple Contingencies occurring within one minute or less of each other shall be treated as a single Contingency. If the combined magnitude of the multiple Contingencies exceeds the most severe single Contingency, the loss shall be reported, but excluded from compliance evaluation.

NERC's proposal, however, is not adequately supported. NERC interprets the exclusion language in the Additional Compliance Information section asrelieving Balancing Authorities or Reserve Sharing Groups from having to comply with the ACE restoration obligation in Requirement R4 for certain Disturbances. However, this understanding is not supported by Requirement R4 or the Additional Compliance Information section. Furthermore, NERC does not explain how the proposed interpretation naturally flows from the existing provision.

22. A more natural reading of the standard is that the exclusion language in the Additional Compliance Information section applies to the Levels of Non-Compliance section contained in BAL-002-1, Part D, Section 2, which provides that:

Each Balancing Authority or Reserve Sharing Group not meeting the DCS during a calendar quarter shall increase its Contingency Reserve obligation for the calendar quarter…following the evaluation by the NERC or Compliance Monitor… The increase shall be directly proportional to the non-compliance with the DCS in the preceding quarter. This adjustment … is an additional percentage of reserve needed beyond the most severe single Contingency.”

This language indicates that each Balancing Authority or Reserve Sharing Group is subject to acompliance evaluationconducted by “the NERC or Compliance Monitor” to determine whether it has complied with the Disturbance Control Standard (DCS) and, if the Balancing Authority or Reserve Sharing Group has not complied, make a temporary upward adjustment to its Contingency Reserve. The exclusion language in the Additional Compliance Information section provides that, for multiple contingency Disturbances, the Balancing Authority or Reserve Sharing Group must report the event, but may exclude it from the evaluation of whether an upward adjustment in Contingency Reserves is warranted. NERC does not explain why the exclusion language in the Additional Compliance Information section applies to the ACE restoration obligation in Requirement R4 rather than the reserve obligation review process described in the Levels of Non-Compliance section of BAL-002-1. Thus, while NERC advocates reading the Reliability Standard as “an integrated whole,”27NERC's interpretation fails to address other relevant language in BAL-002-1.

27NERC Petition at 10.

23. Accordingly, we propose to remand NERC's proposed interpretation as an impermissible change to BAL-002-1 outside the formal standards development process.28The Petition goes beyond a clarification by redefining key terms that would change the plain language of a requirement. The Commission seeks comments on its proposal.

28Our proposal is based on the current wording of BAL-002-1 and does not prejudge the merits of any formal proposal by NERC to replace to or change the wording of BAL-002-1. To the extent NERC and its stakeholders have concerns with the requirements of BAL-002-1, they may seek to address these concerns through the standards development process.

IV. Information Collection Statement

24. The Office of Management and Budget (OMB) regulations require that OMB approve certain reporting and recordkeeping (collections of information) imposed by an agency.29The information contained here is also subject to review under section 3507(d) of the Paperwork Reduction Act of 1995.30

295 CFR 1320.11.

3044 U.S.C. 3507(d).

25. As stated above, the Commission previously approved, in letter order RD10-15, the Reliability Standard that is the subject of the current rulemaking. This proposed rulemaking proposes to remand the Interpretation of BAL-002-1. Accordingly, the proposed Commission action would not affect the information reporting burden.

V. Environmental Analysis

26. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.31The Commission has categorically excluded certain actions from this requirement as not having a significant effect on the human environment. Included in the exclusion are rules that are clarifying, corrective, or procedural or that do not substantially change the effect of the regulations being amended.32The actions proposed herein fall within this categorical exclusion in the Commission's regulations.

27. The Regulatory Flexibility Act of 1980 (RFA)33generally requires a description and analysis of proposed rules that will have significant economic impact on a substantial number of small entities. The RFA mandates consideration of regulatory alternatives that accomplish the stated objectives of a proposed rule and that minimize any significant economicimpact on a substantial number of small entities. The Small Business Administration's Office of Size Standards develops the numerical definition of a small business.34For electric utilities, a firm is small if, including its affiliates, it is primarily engaged in the transmission, generation and/or distribution of electric energy for sale and its total electric output for the preceding twelve months did not exceed four million megawatt hours. The Commission does not expect the proposed remand discussed herein to materially change the cost for small entities to comply with BAL-002-1. Therefore, the Commission certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities.

335 U.S.C. 601-612.

34See13 CFR 121.201.

VII. Comment Procedures

28. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due July 8, 2013. Comments must refer to Docket No. RM13-6-000, and must include the commenter's name, the organization they represent, if applicable, and their address in their comments.

29. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's Web site athttp://www.ferc.gov.The Commission accepts most standard word processing formats. Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. Commenters filing electronically do not need to make a paper filing.

30. Commenters that are not able to file comments electronically must send an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.

31. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters.

VIII. Document Availability

32. In addition to publishing the full text of this document in theFederal Register,the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through the Commission's Home Page (http://www.ferc.gov) and in the Commission's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington DC 20426.

33. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

34. User assistance is available for eLibrary and the Commission's Web site during normal business hours from the Commission's Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email atferconlinesupport@ferc.gov,or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659. Email the Public Reference Room atpublic.referenceroom@ferc.gov.

Several body systems in our Listing of Impairments (listings) contain listings for children based on impairment of linear growth or weight loss. We propose to replace those listings with new listings, add a listing to the genitourinary body system for children, and provide new introductory text for each listing explaining how to apply the new criteria. The proposed revisions to our listings reflect our program experience, advances in medical knowledge, comments we received from medical experts and the public at an outreach policy conference, and comments we received in response to a notice of intent to issue regulations and request for comments (request for comments) and an advance notice of proposed rulemaking (ANPRM). We are also proposing conforming changes in our regulations for title XVI of the Social Security Act (Act).

DATES:

To ensure that your comments are considered, we must receive them by no later than July 22, 2013.

ADDRESSES:

You may submit comments by any one of three methods—Internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2011-0081 so that we may associate your comments with the correct regulation.

Caution: You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.

1.Internet:We strongly recommend that you submit your comments via the Internet. Please visit the Federal eRulemaking portal athttp://www.regulations.gov.Use theSearchfunction to find docket number SSA-2011-0081. The system will issue a tracking number to confirm your submission. You will not be able to view your comment immediately because we must post each comment manually. It may take up to a week for your comment to be viewable.

Comments are available for public viewing on the Federal eRulemaking portal athttp://www.regulations.govor in person, during regular business hours, by arranging with the contact person identified below.

• Comprehensively revise 100.00, the Growth Impairment body system for children. We would apply the new listings in the body system only to infants who were born with low birth weight and to children who have not attained age 3 who fail to grow at the expected rate and have developmental delay (failure to thrive or FTT) as a listing level condition. We would no longer have impairment listings for linear growth alone.

• Revise listing 105.08 in the Digestive System. We would replace references to measurements on the latest versions of the Centers for Disease Control and Prevention's (CDC) growth charts with weight-for-length growth tables that we currently use for children from birth to attainment of age 2, and the body mass index (BMI)-for-age growth tables that we currently use for children age 2 to attainment of age 18. We would also provide more detailed listing criteria and guidance for applying the revised listing.

• Revise listings in the respiratory, cardiovascular, and immune systems that refer to the CDC's or other growth charts to incorporate the tables and other criteria we are proposing for listing 105.08. We would also refer to the tables in proposed listing 105.08 in one of the listings we are proposing for growth failure in children. In addition, we propose to add a listing in the Genitourinary Impairments body system similar to the listings in the other body systems.

• Revise the introductory text and listings to use the term “growth failure” for the body systems with growth listings. Our program experience shows that we are more likely to see the term “growth failure” in medical evidence than other terms now in our listings. The term “growth failure” includes impairment of linear and weight growth.

Why are we proposing these revisions?

We propose these revisions to reflect medical advances and our program experience. We last published final rules making comprehensive revisions to the growth section for children (people under age 18), section 100.00, on December 6, 1985.1We last published final rules revising 105.08 in the digestive system on October 19, 2007.2In the preamble to those rules, we indicated that we would periodically review and update the listings in light of our program experience and medical advances. Since that time, however, we have only extended the effective date of the rules.3

150 FR 50068.

272 FR 59398.

3We published technical revisions to the listings on April 24, 2002. 67 FR 20018. These revisions included changes to the growth impairment and digestive system listings for children, but the revisions were not comprehensive. We extended the expiration date of the current listings for several body systems, including the growth impairment and digestive system listings, in final rules published on June 13, 2012. 77 FR 35264. The final rules extended the date on which the current growth impairment listings will no longer be effective to July 1, 2014 and the date on which the current digestive system listings will no longer be effective to April 1, 2014. 77 FR 35265.

How did we develop these proposed revisions?

In developing these proposed revisions, we considered public comments received in response to the request for comments and the ANPRM we published in theFederal Registeron June 14, 2000 and September 8, 2005.4In the request for comments and ANPRM, we announced our plans to update and revise the growth impairment listings, and we invited interested parties to send us written comments and suggestions.5On November 18, 2005, we hosted a policy outreach conference on “Growth Disorders in the Disability Programs” in Atlanta, Georgia.6From August 25 through 26, 2005, we hosted a policy outreach conference on “Respiratory Disorders in the Disability Programs” in Chicago, Illinois.7We also considered the Institute of Medicine consensus report,HIV and Disability: Updating the Social Security Listings,in setting CD4 values in combination with growth failure in children.8

4June 14, 2000 (65 FR 37321) and September 8, 2005 (70 FR 53323).

5Although we indicated that we would not summarize or respond to the comments, we read and considered them carefully. You can read the September 8, 2005 ANPRM and the comments we received in response to the ANPRM athttp://www.regulations.gov.Use theSearchfunction to find docket number SSA-2006-0181. You can read the June 14, 2000 request for comments athttps://federalregister.gov/a/00-14841.

6You can read a transcript of the policy conference athttp://www.regulations.gov.Use theSearchfunction to find document ID number SSA-2006-0181-0002.

7You can read the transcript of the policy conference athttp://www.regulations.gov.Use theSearchfunction to find document ID number SSA-2006-0149-0002.

8Institute of Medicine. (2010).HIV and disability: Updating the Social Security Listings.Washington, DC: The National Academies Press.

We also considered information from a variety of sources, including:

• Individual medical experts in the field of growth and development, experts in related fields, representatives from advocacy groups for people with growth and developmental disorders, and people with growth and developmental disorders;

• People who make and review disability determinations and decisions for us in State agencies, in our Office of Quality Performance, and in our Office of Disability Adjudication and Review; and

• The published sources we list in the References section at the end of this preamble.

What revisions are we proposing and why are we proposing them?Current section 100.00, Growth Impairment

We propose to change the name of this section to “Low Birth Weight and Failure to Thrive” to reflect the proposed changes to the listings. We also propose to revise the introductory text to reflect that we no longer use linear growth alone in the proposed listings. The proposed introductory text explains the conditions we evaluate in this section and provides guidance on how to apply the proposed listings.

Additionally, we propose to explain in section 100.00C.2.d that under listing 100.05A for growth failure, any measurements taken before the child attains age 2 can be used to evaluate the impairment under the appropriate listing for the child's age. These measurements must be taken within a 12-month period and be at least 60 days apart. A child who attains age 3 could no longer be evaluated under these listings. However, the measurements could be used to evaluate the child's impairment under the most affected body system.

Current Listings 100.02 and 100.03, Growth Impairment

We propose to delete these listings because they are based on linear (height) growth alone. Our adjudicative experience has shown that a declining linear growth rate is not always indicative of a disabling condition and that short stature in itself is not disabling.

Proposed Listing 100.04, Low Birth Weight in Infants From Birth To Attainment of Age 1

We currently find low birth weight (LBW) infants disabled until the attainment of age 1 under examples 6 and 7 in our functional equivalence rule.9We believe that it is simpler to provide a listing for these children. In example 6, we currently find infants from birth to the attainment of age 1 whose birth weight satisfy the objective criteria to be disabled. In example 7, we currently find children whose birthweight and gestational age satisfy the objective criteria to be disabled.

9See § 416.926a(m)(6) and (m)(7).

We also propose to provide a table of gestational ages and birth weights that will help adjudicators determine when an infant's birth weight, in combination with his or her gestational age, meets the criteria for LBW under the proposed listing.

We would explain in proposed 100.00B that, for impairments that meet the requirements in proposed listing 100.04A or 100.04B, we would follow the guidance in our regulations for considering LBW claims for medical reviews.10

10See § 416.990(b)(11).

Proposed Listing 100.05, Failure To Thrive in Children From Birth To Attainment Of Age 3

We currently provide guidance in our operating instructions for adjudicators to evaluate failure to thrive (FTT) in children from birth to attainment of age 2 under 105.08, the listing for malnutrition due to a digestive disorder.11If the child does not have a digestive disorder, we determine whether the child's growth disorder medically equals the digestive listing. This determination can be especially difficult when there are no identifiable or distinctive physical findings related to the child's FTT that an adjudicator could compare to the nutritional deficiency findings required in 105.08A. We are proposing listing 100.05 in which we would evaluate FTT in children from birth to attainment of age 3 regardless of whether there is a known cause for the child's growth failure.

11POMS DI 24550.001 athttps://secure.ssa.gov/poms.nsf/lnx/0424550001.

Under our program rules, FTT can be a medically determinable impairment because it results from anatomical, physiological, or psychological abnormalities shown by medically acceptable clinical and laboratory diagnostic techniques. There is, however, no single definition or description of FTT. Medical sources reference various growth charts and growth percentiles for establishing FTT. Some medical sources establish a diagnosis of FTT based on the child's growth failure and various degrees of developmental delay. Others establish FTT based on growth failure alone. In proposed 100.05, we would require documentation of both growth failure and developmental delay to establish FTT as a listing-level condition because our program experience has shown that growth failure alone is not disabling.

In proposed 100.05A, we would evaluate growth failure by using the appropriate table(s) under proposed 105.08B in the digestive system to determine whether a child's growth is less than the third percentile. We would require three weight-for-length measurements for children from birth to attainment of age 2 or three body mass index (BMI)-for-age measurements for children age 2 to attainment of age 3 that are within a consecutive 12-month period and at least 60 days apart. If a child attains age 2 during the adjudication period, measurements taken before the child attains age 2 can be used to evaluate the impairment under the appropriate listing for the child's age, if the measurements were obtained within a 12-month period and are at least 60 days apart. We believe this number and interval of measurements over a consecutive 12-month period would establish that an infant's or a toddler's rate of growth reflects actual growth failure and not a short-term delay in rate of growth. This guidance on growth measurements apply to all affected body systems. The child does not have to have a digestive disorder for the purposes of proposed 100.05.

In proposed 100.05B, we would require a report from an acceptable medical source that establishes the appropriate level of delay in a child's development. Acceptable medical sources or early intervention specialists, physical or occupational therapists, and other sources may conduct standardized developmental assessments and developmental screenings.12The results of these tests and screenings must include a statement or records from an acceptable medical source indicating the child has a developmental delay. We would document the severity of the developmental delay with test results from a standardized developmental assessment that compares a child's level of development to the level typically expected for his or her chronological age. The required level of severity would be met if the test results indicate that the child's development is not more than two-thirds of the level typically expected for the child's age or results in a valid score that is at least two standard deviations below the mean.

12See, §§ 404.1513(a) and 416.913(a).

In proposed 100.05C, we would require developmental delay established by an acceptable medical source and documented by findings from two narrative developmental reports dated at least 120 days apart that indicate development not more than two-thirds of the level typically expected for a child's age. We would require the narrative report to include the child's developmental history, physical examination findings, and an overall assessment of the child's development (that is, more than one or two isolated skills) by the acceptable medical source. Abnormal findings noted on repeated examinations, and information in narrative developmental reports, that may include the results of developmental screening tests, can identify a child who is not developing or achieving skills within expected timeframes.

Our current operating instructions limit evaluation of FTT to children from birth to attainment of age 2. We would extend the age limit in the proposed listing because our adjudicative experience indicates that FTT may continue to attainment of age 3. Our adjudicative experience has been that, by age 3, most children who develop or continue to experience growth failure will have an identifiable cause for their growth failure, which we evaluate under the affected body system.

We propose to add 103.06, under the respiratory body system, for evaluating growth failure in children with chronic respiratory disorders because growth failure is a common complication of chronic respiratory disorders in children. We would add the same growth failure criteria as proposed in 105.08B. We would also provide guidance in the introductory text to adjudicators on how to evaluate growth failure under the proposed listing.

Proposed Listing 104.02C

We propose to revise 104.02C, under the cardiovascular body system, to conform to criteria we are proposing to growth listings in other body systems. We also propose to change the current title of the listing fromGrowth disturbance withtoGrowth failure as required in 1 or 2.We would add the same growth failure criteria as proposed in 105.08B. We would also provide guidance in the introductory text on how to evaluate growth failure under the proposed listing.

Proposed Listing 105.08, Growth Failure Due to Any Digestive Disorder

We propose to revise the title of listing 105.08, under the digestive body system, to changeMalnutrition due to any digestive disordertoGrowth failure due to any digestive disorder.We would provide guidance in the introductory text on how to evaluate growth failure under the proposed listing.

We propose to revise the current criteria in 105.08A. We would require two laboratory values at least 60 days apart within a consecutive 12-month period instead of a consecutive 6-month period to be consistent with pediatric standards of care for evaluating growth over time. We would remove the phrase “despite continuing treatment as prescribed” because we address the issue of following prescribed treatment elsewhere in our rules.13We would also remove current 105.08A3 because the criterion is no longer a good indicator of nutritional deficiency. As a result of advances in medical therapy, the vitamin or mineral deficiencies referred to in the current listing can be supplemented in the diet.

13See § 416.930.

We would change the title of 105.08B fromGrowth retardation documented by one of the followingtoGrowth failure as required in 1 or 2.We would also require at least 60 days between the growth measurements to be consistent with similar rules in other body systems.

In proposed 105.08B, we would add the weight-for-length growth tables that we currently use for children from birth to attainment of age 2, and the body mass index (BMI)-for-age growth tables that we use for children age 2 to attainment of age 18, both of which are in our current operating instructions for determining growth failure.14We would no longer refer adjudicators to the Centers for Disease Control and Prevention's (CDC's) latest recommended growth charts. In making this proposed change, we considered the CDC's recently published revised growth charts for children that adopt the World Health Organization (WHO) standards for monitoring growth in children birth to age 2.15There are several reasons why we did not adopt these growth charts for purposes of evaluating growth under our listings. The WHO's growth charts use a 2.3 percentile standard to represent two standard deviations below the mean and describe the growth of healthy children in optimal conditions. However, we currently evaluate growth failure based on growth measurements that are less than the 3.0 or third percentile of the tables in our current operating instructions to represent two standard deviations below the mean. Additionally, the 3.0 or third percentile based on the WHO's growth charts would identify fewer children than our current third percentile tables, which we base on CDC's growth charts prior to their adoption of the WHO recommended growth standards.

14POMS DI 24550.001 Weight-for-Length Table (Birth to the Attainment of Age 2) athttp://policynet.ba.ssa.gov/poms.nsf/lnx/0424550001.andPOMS DI 24550.002 Body-Mass-Index-for-Age Tables (Age 2 to the Attainment of Age 18) athttps://secure.ssa.gov/apps10/poms.nsf/lnx/0424550002.

15The CDC's Growth Charts athttp://www.cdc.gov/growthcharts/.

The third percentile BMI-for-age tables we propose to add to listing 105.08B for children age 2 to attainment of age 18 are based on CDC's current BMI-for-age growth charts. We propose adding the third percentile tables in 105.08B instead of growth charts because, in our adjudicative experience, we have found that plotted growth charts are not always included in a child's medical records whereas weight and length or weight measurements are. It is also simpler for our adjudicators to apply the measurements to the third percentile tables rather than plotting measurements themselves on a growth chart. Using weight-for-length measurements also means that adjudicators do not need to adjust for prematurity.

We believe that it remains programmatically correct for us to continue to determine growth failure for children from birth to attainment of age 18 using the tables currently in our operating instructions. We believe that children who have growth measurements that are less than the third percentile, and have another impairment with marked limitations as described in each of the proposed listings containing growth criteria, are disabled.

We propose to add 106.08, under the genitourinary body system, for evaluating growth failure in children with chronic renal disease because growth failure is a common complication of chronic renal disease in children. The kidneys regulate the amounts and interactions of nutrients, including proteins, minerals, and vitamins, necessary for growth. Impaired kidney function and the side effects of treatment may decrease a child's appetite and further limit the utilization of these nutrients, resulting in growth failure. We would add the same growth failure criteria as proposed in 105.08B. We would also provide guidance in the introductory text on how to evaluate growth failure under the proposed listing.

Proposed Listing 114.08H, Immune Suppression and Growth Failure

We propose to revise 114.08H, under the immune body system, for children with growth failure due to HIV-induced immune suppression to conform to criteria we are proposing for growth listings in other body systems. We would remove the current weight-loss criteria and add laboratory criteria and the same growth failure criteria as proposed in 105.08B. We propose to quantify the degree of HIV-induced immune suppression by specifying CD4 laboratory criteria for different ages, following accepted medical standards of care. We would also provide guidance in the introductory text on how to evaluate growth failure under the proposed listing.

Other Changes

We also propose the following conforming changes:

• Revise § 416.924b(b) to reflect the removal of listings 100.002 and 100.03 and the addition of 100.04;

• Revise § 416.926a(m) by removing examples 6 and 7 for children with low birth weight because we are providing listings with these specific criteria; and

16Section 416.934 provides a list of impairment categories that employees in our field offices may use to make findings of presumptive disability in SSI claims without obtaining any medical evidence. We may make SSI payments based on presumptive disability or presumptive blindness when there is a high probability that we will find a claimant disabled or blind when we make our formal disability determination at the initial level of our administrative review process. § 416.933.

What is our authority to make rules and set procedures for determining whether a person is disabled under the statutory definition?

Under the Act, we have full power and authority to make rules and regulations and to establish necessary and appropriate procedures to carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1).

How long would these proposed rules be effective?

If we publish these proposed rules as final rules, they will remain in effect for 5 years after the date they become effective unless we extend them or revise and issue them again.

Clarity of These Proposed Rules

Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on theseproposed rules, we invite your comments on how to make them easier to understand.

For example:

• Would more, but shorter, sections be better?

• Are the requirements in the rules clearly stated?

• Have we organized the material to suit your needs?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rules easier to understand?

• Do the rules contain technical language or jargon that is not clear?

• Would a different format make the rules easier to understand, e.g., grouping and order of sections, use of headings, paragraphing?

When will we start to use these rules?

We will not use these rules until we evaluate public comments and publish final rules in theFederal Register. All final rules we issue include an effective date. We will continue to use our current rules until that date. If we publish final rules, we will include a summary of those relevant comments we received along with responses and an explanation of how we will apply the new rules.

Regulatory ProceduresExecutive Order 12866, as Supplemented by Executive Order 13563

We consulted with the Office of Management and Budget (OMB) and determined that these proposed rules meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed them.

Regulatory Flexibility Act

We certify that these proposed rules would not have a significant economic impact on a substantial number of small entities because they affect individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

These proposed rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.

References

We consulted the following references when we developed these proposed rules:

Council on Children with Disabilities, Section on Developmental Behavioral Pediatrics. (2006). Identifying infants and young children with developmental disorders in the medical home: An algorithm for developmental surveillance and screening.American Academy of Pediatrics, 118(1), 405-420. doi:10.1542/peds.2006-1231

Gayle, H., Dibley, M., Marks, J., & Trowbridge, F. (1987). Malnutrition in the first two years of life: The contribution of low birth weight to population estimates in the United States.American Journal of Diseases of Children, 141(5), 531-534. doi:10.1001/archpedi.1987.04460050073034

Grummer-Strawn, L.M., Krebs, N.F., & Reinhold, C. (2010). Use of world health organization and CDC growth charts for children aged 0-59 months in the United States.Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report, 59(RR-09), 1-15. Retrieved fromhttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5909a1.htm

Institute of Medicine. (2010).Cardiovascular disability: Updating the Social Security listings.Washington, DC: The National Academies Press.

We will make these references available to you for inspection if you are interested in reading them. Please make arrangements with the contact person shown in this preamble if you would like to review any reference materials.

1. Low Birth Weight and Failure To Thrive (100.00): [DATE 5 YEARS FROM THE EFFECTIVE DATE OF THE FINAL RULE].

Part B

100.00Low Birth Weight and Failure To Thrive.

100.00LOW BIRTH WEIGHT AND FAILURE TO THRIVE

A.What conditions do we evaluate under these listings?We evaluate low birth weight (LBW) in infants from birth to attainment of age 1 and failure to thrive (FTT) in infants and toddlers from birth to attainment of age 3.

B.How do we evaluate disability based on LBW under 100.04?In 100.04A and 100.04B, we use an infant's birth weight as documented by an original or certified copy of the infant's birth certificate or by a medical record signed by a physician.Birth weightmeans the first weight recorded after birth. In 100.04B,gestational ageis the infant's age based on the date of conception as recorded in the medical record. If your impairment meets the requirements for listing 100.04A or 100.04B, we will follow the rules in § 416.990(b)(11) of this chapter.

C.How do we evaluate disability based on FTT under 100.05?

1.General.We establish FTT with or without a known cause when we have documentation of an infant's or a toddler's growth failure and developmental delay from an acceptable medical source(s) as defined in § 416.913(a) of this chapter. We require documentation of growth measurements in 100.05A and developmental delay described in 100.05B or 100.05C within the same consecutive 12-month period. The dates of developmental testing and reports may be different from the dates of growth measurements. After the attainment of age 3, we evaluate growth failure under the affected body system(s).

2.Growth failure.Under 100.05A, we use the appropriate table(s) under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile. The child does not need to have a digestive disorder for purposes of 100.05.

a. For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II).

b. For children age 2 to attainment of age 3, we use the body mass index (BMI)-for-age table corresponding to the child's gender (Table III or Table IV).

c. BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.

d.Growth measurements.The weight-for-length measurements for children birth to the attainment of age 2 and body mass index (BMI)-for-age measurements for children age 2 to attainment of age 3 that are required for this listing must be obtained within a 12-month period and at least 60 days apart. If a child attains age 2 during the evaluation period additional measurements are not needed. Any measurements taken before the child attains age 2 can be used to evaluate the impairment under the appropriate listing for the child's age. If the child attains age 3 during the evaluation period, the measurements can be used to evaluate them in the most affected body system.

3.Developmental delay.

a. Under 100.05B and C, we use reports from acceptable medical sources to establish delay in a child's development.

b. Under 100.05B, we document the severity of developmental delay with results from a standardized developmental assessment, which compares a child's level of development to the level typically expected for his or her chronological age. If the child was born prematurely, we may use the corrected chronological age (CCA) for comparison. (See § 416.924b(b) of this chapter.) CCA is the chronological age adjusted by a period of gestational prematurity. CCA = (chronological age)−(number of weeks premature). Acceptable medical sources or early intervention specialists, physical or occupational therapist, and other sources may conduct standardized developmental assessments and developmental screenings. The results of these tests and screenings must be accompanied by a statement or records from an acceptable medical source who established the child has a developmental delay.

c. Under 100.05C, when there are no results from a standardized developmental assessment in the case record, we need narrative developmental reports from the child's medical sources in sufficient detail to assess the severity of his or her developmental delay. A narrative developmental report is based on clinical observations, progress notes, and well-baby check-ups. To meet the requirements for 100.05C, the report must include: the child's developmental history; examination findings (with abnormal findings noted on repeated examinations); and an overall assessment of the child's development (that is, more than one or two isolated skills) by the medical source. Some narrative developmental reports may include results from developmental screening tests, which can identify a child who is not developing or achieving skills within expected timeframes. Although medical sources may refer to screening test results as supporting evidence in the narrative developmental report, screening test results alone cannot establish a diagnosis or the severity of developmental delay.

D.How do we evaluate disorders that do not meet one of these listings?

1. We may find infants disabled due to other disorders when their birth weights are greater than 1200 grams but less than 2000 grams and their weight and gestational age do not meet 100.04. The most common disorders of prematurity and LBW include retinopathy of prematurity (ROP), chronic lung disease of infancy (CLD, previously known as bronchopulmonary dysplasia, or BPD), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), and periventricular leukomalacia (PVL). Other disorders include poor nutrition and growth failure, hearing disorders, seizure disorders, cerebral palsy, and developmental disorders. We evaluate these disorders under the affected body systems.

2. We may evaluate infants and toddlers with growth failure that is associated with a known medical disorder under the body system of that medical disorder, for example, the respiratory or digestive body systems.

3. If an infant or toddler has a severe medically determinable impairment(s) that does not meet the criteria of any listing, we must also consider whether the child has an impairment(s) that medically equals a listing (see § 416.926 of this chapter). If the child's impairment(s) does not meet or medically equal a listing, we will determine whether the child's impairment(s) functionally equals the listings (see § 416.926a of this chapter) considering the factors in § 416.924a of this chapter. We use the rules in section § 416.994a of this chapter when we decide whether a child continues to be disabled.

100.01Category of Impairments, Low Birth Weight and Failure To Thrive.

100.05Failure to thrive in children from birth to attainment of age 3 (see 100.00C), documented by A and B, or A and C.

A. Growth failure as required in 1 or 2:

1.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate weight-for-length table in listing 105.08B1; or

2.For children age 2 to attainment of age 3,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate BMI-for-age table in listing 105.08B2.

AND

B. Developmental delay (see 100.00C1 and C3), established by an acceptable medical source and documented by findings from one report of a standardized developmental assessment (see 100.00C3b) that:

1. Shows development not more than two-thirds of the level typically expected for the child's age; or

2. Results in a valid score that is at least two standard deviations below the mean.

OR

C. Developmental delay (see 100.00C3), established by an acceptable medical source and documented by findings from two narrative developmental reports (see 100.00C3c) that:

1. Are dated at least 120 days apart (see 100.00C1); and

2. Indicate development not more than two-thirds of the level typically expected for the child's age.

103.00RESPIRATORY SYSTEM

F.How do we evaluate growth failure due to any chronic respiratory disorder?

1. To evaluate growth failure due to any chronic respiratory disorder, we require documentation of the oxygen supplementation described in 103.06A and the growth measurements in 103.06B within the same consecutive 12-month period. The dates of oxygen supplementation may be different from the dates of growth measurements.

2. Under 103.06B, we use the appropriate table(s) under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile.

a. For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II).

b. For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table corresponding to the child's gender (Table III or Table IV).

c. BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.

A. Hypoxemia with the need for at least 1.0 L/min of oxygen supplementation for at least 4 hours per day and for at least 90 consecutive days.

AND

B. Growth failure as required in 1 or 2:

1.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate weight-for-length table under 105.08B1; or

2.For children age 2 to attainment of age 18,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate BMI-for-age table under 105.08B2.

104.00CARDIOVASCULAR SYSTEM

C.Evaluating Chronic Heart Failure.

2.What evidence of CHF do we need?

b. To establish that you havechronicheart failure, we require that your medical history and physical examination describe characteristic symptoms and signs of pulmonary or systemic congestion or of limited cardiac output associated with abnormal findings on appropriate medically acceptable imaging. When a remediable factor, such as arrhythmia, triggers an acute episode of heart failure, you may experience restored cardiac function, and a chronic impairment may not be present.

(ii) During infancy, other manifestations of chronic heart failure may include repeated lower respiratory tract infections.

3.How do we evaluate growth failure due to CHF?

a. To evaluate growth failure due to CHF, we require documentation of the clinical findings of CHF described in 104.00C2 and the growth measurements in 104.02C within the same consecutive 12-month period. The dates of clinical findings may be different from the dates of growth measurements.

b. Under 104.02C, we use the appropriate table(s) under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile.

(i) For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II).

(ii) For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table corresponding to the child's gender (Table III or Table IV).

(iii) BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.

104.02Chronic heart failurewhile on a regimen of prescribed treatment, with symptoms and signs described in 104.00C2 and with one of the following:

C. Growth failure as required in 1 or 2:

1.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate weight-for-length table under 105.08B1; or

2.For children age 2 to attainment of age 18,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate BMI-for-age table under 105.08B2.

105.00DIGESTIVE SYSTEM

G.How do we evaluate growth failure due to any digestive disorder?

1. To evaluate growth failure due to any digestive disorder, we require documentation of the laboratory findings of chronic nutritional deficiency described in 105.08A and the growth measurements in 105.08B within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements.

2. Under 105.08B, we evaluate a child's growth failure by using the appropriate table for age and gender.

a. For children from birth to attainment of age 2, we use the weight-for-length table (see Table I or Table II).

b. For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table (see Tables III or IV).

c. BMI is the ratio of a child's weight to the square of the child's height. We calculate BMI using one of the following formulas:

105.08Growth failure due to any digestive disorder(see 105.00G), documented by A and B:

A. Chronic nutritional deficiency present on at least two evaluations at least 60 days apart within a consecutive 12-month period documented by one of the following:

1. Anemia with hemoglobin less than 10.0 g/dL; or

2. Serum albumin of 3.0 g/dL or less;

AND

B. Growth failure as required in 1 or 2:

1.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on Table I or Table II; or

Table I—Males Birth to Attainment of Age 2 Third Percentile Values for Weight-for-LengthLength

(centimeters)

Weight

(kilograms)

Length

(centimeters)

Weight

(kilograms)

Length

(centimeters)

Weight

(kilograms)

45.01.59764.56.13284.510.30145.51.70365.56.35985.510.49946.51.91966.56.58486.510.69647.52.13967.56.80787.510.89548.52.36468.57.02788.511.09549.52.59269.57.24589.511.29650.52.82470.57.46190.511.49851.53.05871.57.67491.511.70352.53.29472.57.88592.511.91053.53.53273.58.09493.512.11954.53.77174.58.30194.512.33155.54.01075.58.50795.512.54656.54.25076.58.71096.512.76457.54.48977.58.91397.512.98758.54.72878.59.11398.513.21359.54.96679.59.31399.513.44360.55.20380.59.512100.513.67861.55.43881.59.710101.513.91862.55.67182.59.907102.514.16363.55.90383.510.104103.514.413Table II—Females Birth to Attainment of Age 2 Third Percentile Values for Weight-for-LengthLength

2.For children age 2 to attainment of age 18,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on Table III or Table IV.

Table III—Males Age 2 to Attainment of Age 18 Third Percentile Values for BMI-for-AgeAge

(yrs. and mos.)

BMIAge

(yrs. and mos.)

BMIAge

(yrs. and mos.)

BMI2.0 to 2.114.510.11 to 11.214.314.9 to 14.1016.12.2 to 2.414.411.3 to 11.514.414.11 to 15.016.22.5 to 2.714.311.6 to 11.814.515.1 to 15.316.32.8 to 2.1114.211.9 to 11.1114.615.4 to 15.516.43.0 to 3.214.112.0 to 12.114.715.6 to 15.716.53.3 to 3.614.012.2 to 12.414.815.8 to 15.916.63.7 to 3.1113.912.5 to 12.714.915.10 to 15.1116.74.0 to 4.513.812.8 to 12.915.016.0 to 16.116.84.6 to 5.013.712.10 to 13.015.116.2 to 16.316.95.1 to 6.013.613.1 to 13.215.216.4 to 16.517.06.1 to 7.613.513.3 to 13.415.316.6 to 16.817.17.7 to 8.613.613.5 to 13.715.416.9 to 16.1017.28.7 to 9.113.713.8 to 13.915.516.11 to 17.017.39.2 to 9.613.813.10 to 13.1115.617.1 to 17.217.49.7 to 9.1113.914.0 to 14.115.717.3 to 17.517.510.0 to 10.314.014.2 to 14.415.817.6 to 17.717.610.4 to 10.714.114.5 to 14.615.917.8 to 17.917.710.8 to 10.1014.214.7 to 14.816.017.10 to 17.1117.8Table IV—Females Age 2 to Attainment of Age 18Third Percentile Values for BMI-for-AgeAge

(yrs. and mos.)

BMIAge

(yrs. and mos.)

BMIAge

(yrs. and mos.)

BMI2.0 to 2.214.110.8 to 10.1014.014.3 to 14.515.62.3 to 2.614.010.11 to 11.214.114.6 to 14.715.72.7 to 2.1013.911.3 to 11.514.214.8 to 14.915.82.11 to 3.213.811.6 to 11.714.314.10 to 15.015.93.3 to 3.613.711.8 to 11.1014.415.1 to 15.216.03.7 to 3.1113.611.11 to 12.114.515.3 to 15.516.14.0 to 4.413.512.2 to 12.414.615.6 to 15.716.24.5 to 4.1113.412.5 to 12.614.715.8 to 15.1016.35.0 to 5.913.312.7 to 12.914.815.11 to 16.016.45.10 to 7.613.212.10 to 12.1114.916.1 to 16.316.57.7 to 8.413.313.0 to 13.215.016.4 to 16.616.68.5 to 8.1013.413.3 to 13.415.116.7 to 16.916.78.11 to 9.313.513.5 to 13.715.216.10 to 17.016.89.4 to 9.813.613.8 to 13.915.317.1 to 17.316.99.9 to 10.013.713.10 to 14.015.417.4 to 17.717.010.1 to 10.413.814.1 to 14.215.517.8 to 17.1117.110.5 to 10.713.9106.00GENITOURINARY IMPAIRMENTS

E.What other things do we consider when we evaluate your genitourinary impairment under specific listings?

5.Growth failure due to any chronic renal disease (106.08).

a. To evaluate growth failure due to any chronic renal disease, we require documentation of the laboratory findings described in 106.08A and the growth measurements in 106.08B within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements.

b. Under 106.08B, we use the appropriate table(s) under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile.

(i) For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II).

(ii) For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table corresponding to the child's gender (Table III or Table IV).

(iii) BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.

106.08Growth failure due to any chronic renal disease(see 106.00E5), with:

A. Serum creatinine of 2 mg/dL or greater, documented at least two times within a consecutive 12-month period with at least 60 days between measurements.

AND

B. Growth failure as required in 1 or 2:

1.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate weight-for-length table under 105.08B1; or

2.For children age 2 to attainment of age 18,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate BMI-for-age table under 105.08B2.

(i) To evaluate growth failure due to HIV immune suppression, we require documentation of the laboratory values described in 114.08H1 and the growth measurements in 114.08H2 or 114.08H3 within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements.

(ii) Under 114.08H2 and 114.08H3, we use the appropriate table under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile.

A. For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II).

B. For children age 2 to attainment of age 18, we use the body mass index (BMI)-for-age table corresponding to the child's gender (Table III or Table IV).

C. BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c.

114.08Human immunodeficiency virus (HIV) infection.* * *

H.Immune suppression and growth failure(see 114.00F4d) documented by 1 and 2, or by 1 and 3.

1. CD4 measurement:

a.For children from birth to attainment of age 5,CD4 percentage of less than 20 percent; or

b.For children age 5 to attainment of age 18,absolute CD4 count of less than 200 cells/mm3, or CD4 percentage of less than 14 percent; and

2.For children from birth to attainment of age 2,three weight-for-length measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate weight-for-length table under 105.08B1; or

3.For children age 2 to attainment of age 18,three body mass index (BMI)-for-age measurements that are:

a. Within a consecutive 12-month period; and

b. At least 60 days apart; and

c. Less than the third percentile on the appropriate BMI-for-age table under 105.08B2.

PART 416—SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLEDSubpart I — [Amended]3. The authority citation for subpart I of part 416 continues to read as follows:Authority:

4. Amend § 416.924b by revising paragraph (b) to read as follows:§ 416.924bAge as a factor of evaluation in the sequential evaluation process for children.

(b)Correcting chronological age of premature infants.We generally use chronological age (a child's age based on birth date) when we decide whether, or the extent to which, a physical or mental impairment or combination of impairments causes functional limitations. However, if you were born prematurely, we may consider you younger than your chronological age when we evaluate your development. We may use a “corrected” chronological age (CCA); that is, your chronological age adjusted by a period of gestational prematurity. We consider an infant born at less than 37 weeks' gestation to be born prematurely.

(1) We compute your CCA by subtracting the number of weeks of prematurity (the difference between 40 weeks of full-term gestation and the number of actual weeks of gestation) from your chronological age. For example, if your chronological age is 20 weeks but you were born at 32 weeks gestation (8 weeks premature), then your CCA is 12 weeks.

(2) We evaluate developmental delay in a premature child until the child's prematurity is no longer a relevant factor, generally no later than about chronological age 2.

(i) If you have not attained age 1 and were born prematurely, we will assess your development using your CCA.

(ii) If you are over age 1 and have a developmental delay, and prematurity is still a relevant factor, we will decide whether to correct your chronological age. We will base our decision on our judgment and all the facts in your case. If we decide to correct your chronological age, we may correct it by subtracting the full number of weeks of prematurity or a lesser number of weeks. If your developmental delay is the result of your medically determinable impairment(s) and is not attributable to your prematurity, we will decide not to correct your chronological age.

(3) Notwithstanding the provisions in paragraph (b)(1) of this section, we will not compute a CCA if the medical evidence shows that your treating source or other medical source has already taken your prematurity into consideration in his or her assessment of your development. We will not compute a CCA when we find you disabled under listing 100.04 of the Listing of Impairments.

§ 416.926a[Amended]5. Amend § 416.926a by removing paragraphs (m)(6) and (m)(7) and redesignating paragraph (m)(8) as (m)(6).6. Amend § 416.934 by adding paragraphs (j) and (k) to read as follows:§ 416.934Impairments which may warrant a finding of presumptive disability or presumptive blindness.

(j) Infants weighing less than 1200 grams at birth, until attainment of 1 year of age.

(k) Infants weighing at least 1200 but less than 2000 grams at birth, and who are small for gestational age, until attainment of 1 year of age. (Small for gestational age means a birth weight that is at or more than 2 standard deviations below the mean or that is less than the 3rd growth percentile for the gestational age of the infant.)

PHMSA is proposing to address certain matters identified in the Hazardous Materials Transportation Safety Act of 2012 related to the Department's enhanced inspection, investigation, and enforcement authority. Specifically, we are proposing to amend the opening of packages provision to include requirements for perishable hazardous material; add a new notification section; and add a new equipment section to the Department's procedural regulations. For the mandates to address certain matters related to the Department's enhanced inspection, investigation, and enforcement authority, we are proposing no additional regulatory changes. We believe that the Department's currentrules that were previously established through notice and comment rulemaking and existing policies and operating procedures thoroughly address the hazmat transportation matters identified by Congress. These inspection and enforcement procedures will not change the current inspection procedures for DOT, but will augment DOT's existing enforcement procedures and allow the Department to respond immediately and effectively to conditions or practices that pose serious threats to life, property, or the environment. As this rule affects only agency enforcement procedures, it therefore results in no additional burden of compliance costs to industry.

DATES:

Comments must be received by July 22, 2013. To the extent possible, PHMSA will consider late-filed comments as a final rule is developed.

ADDRESSES:

You may submit comments by identification of the docket number (PHMSA-2012-0259 (HM-258B)) by any of the following methods:

Instructions:All submissions must include the agency name and docket number for this notice at the beginning of the comment. All comments received will be posted without change to the Federal Docket Management System (FDMS), including any personal information.

On July 6, 2012, the President signed the Moving Ahead for Progress in the 21st Century Act, or the MAP-21, which included the Hazardous Materials Transportation Safety Improvement Act of 2012 (HMTSIA) as Title III of the statute. Public Law 112-141, 126 Stat. 405, July 6, 2012. Section 33009 of HMTSIA revised 49 U.S.C. 5121 to include a notification requirement. Congress also directed the Department to address certain hazmat transportation matters through rulemaking:

• The safe and expeditious resumption of transportation of perishable hazardous material, including radiopharmaceuticals and other medical products that may require timely delivery due to life-threatening situations;

• The means by which non-compliant packages that present an imminent hazard are placed out-of-service until the condition is corrected;

• The means by which non-compliant packages that do not present a hazard are moved to their final destination;

• Appropriate training and equipment for inspectors; and

• The proper closure of packaging in accordance with the hazardous material regulations.

We are proposing in this rulemaking, as described further below, to clarify the Department's position with respect to perishable hazardous material, by amending the opening of packages provision of the Department's hazardous materials procedural regulations for the opening of packages, emergency orders, and emergency recalls. The amendment recognizes the special characteristics and handling requirements of perishable hazardous material by clarifying that an agent will stop or open a package containing a perishable hazardous material only after the agent has utilized appropriate alternatives. We are also proposing to codify the statutory notification requirement in HMTSIA by incorporating into the regulations the Department's current notification procedures from the operations manual. Finally, we are proposing to add a new provision to address appropriate equipment for inspectors. For the remaining mandates to address certain matters related to the Department's enhanced inspection, investigation, and enforcement authority, we are proposing no additional regulatory changes. We believe that the Department's current rules that were previously established through notice and comment rulemaking and existing policies and operating procedures thoroughly address the hazmat transportation matters identified by Congress as requiring additional regulations. For instance, in a prior rulemaking, the Department established, in Part 109, procedural regulations for opening packages, removing packages from transportation, and closing packages. These regulations include the definition of key terms, including perishable hazardous material. The regulations address how the Department's agents will handle non-compliant packages that present an imminent hazard and those that do not. Moreover, the rules address when and how the Department's agents will open a package. And, if an agent opens a package, there are procedural rules for closing the package and ensuring its safe resumption of transportation, if applicable. In addition, the Department developed an internal operations manual for training and use by its hazmat inspectors and investigators across all modes of transportation. The operations manual's guidance is intended to target and manage the use of the enhanced inspection and enforcement authority in a uniform and consistent manner within the Department. At this time, we do not have any data or other information that indicate the rules, policies, and operating procedures currently in place are inadequate or that additional regulations are necessary.

II. Background

On March 2, 2011, we issued a final rule under Docket No. PHMSA-2005-22356 (PHM-7), “Hazardous Materials: Enhanced Enforcement Procedures.” 76 FR 11570. The final rule became effective on May 2, 2011. The rule implemented enhanced inspection, investigation, and enforcement authority conferred on the Secretary of Transportation (Secretary) by theHazardous Materials Transportation Safety and Security Reauthorization Act of 2005 (HMTSSRA). The final rule established procedures for issuance of emergency orders (restrictions, prohibitions, recalls, and out-of-service orders) to address unsafe conditions or practices posing an imminent hazard; opening of packages to identify undeclared or non-compliant shipments, when the person in possession of the package refuses a request to open it; and the temporary detention and inspection of potentially non-compliant packages. 76 FR 11570 (codified at 49 CFR, Part 109). In conjunction with the final rule, the Department of Transportation (Department or DOT) developed an internal operations manual for training and use by its inspectors and investigators (collectively agents). The operations manual is a joint document created by the operating administrations that enforce the Hazardous Materials Regulations, 49 CFR parts 171-180 (HMR)1, to provide guidance to agents who, in the course of conducting inspections, determine that they need to open a package, remove a package from transportation, or perform any other authorized function in Part 109. The manual seeks to establish baseline conditions that will ensure consistent application of the authorities exercised under 49 CFR part 109 at a minimum threshold. The guidance is intended to target and manage the use of enhanced inspection and enforcement authority in a manner that minimizes burdens on the transportation system while, at the same time, meets the overriding mission of transportation safety. The operations manual was made available to the public on the PHMSA Web site,http://www.phmsa.dot.gov.

On July 6, 2012, the President signed the Moving Ahead for Progress in the 21st Century Act, or the MAP-21, which included the Hazardous Materials Transportation Safety Improvement Act of 2012 (HMTSIA) as Title III of the statute. Public Law 112-141, 126 Stat. 405, July 6, 2012. Section 33008 of HMTSIA created a mandate for the Department to develop uniform performance standards for hazmat inspectors and investigators:

(a) In General—Not later than 18 months after the date of enactment of this Act, the Secretary shall develop uniform performance standards for training hazardous material inspectors and investigators on—

(1) how to collect, analyze, and publish findings from inspections and investigations of accidents or incidents involving the transportation of hazardous material; and

(2) how to identify noncompliance with regulations issued under chapter 51 of title 49, United States Code, and take appropriate enforcement action.

(B) State employees who conduct federally funded compliance reviews, inspections, or investigations; and

(2) shall be made available to Federal, State, and local hazardous material safety enforcement personnel.

126 Stat. at 836.

Section 33009 of HMTSIA revised 49 U.S.C. 5121, to include a notification requirement. Congress also directed the Department to address certain hazmat transportation matters through rulemaking:

(a) Notice of Enforcement Measures—Section 5121(c)(1) is amended—

(1) in subparagraph (E), by striking “and” at the end;

(2) in subparagraph (F), by striking the period at the end and inserting “; and”; and

(3) by adding at the end the following:

“(G) shall provide to the affected offeror, carrier, packaging manufacturer or tester, or other person responsible for the package reasonable notice of—

“(i) his or her decision to exercise his or her authority under paragraph (1);

“(ii) any findings made; and

“(iii) any actions being taken as a result of a finding of noncompliance.”.

(b) Regulations—

(1) Matters To Be Addressed—Section 5121(e) is amended by adding at the end the following:

“(3) Matters To Be Addressed—The regulations issued under this subsection shall address—

“(A) the safe and expeditious resumption of transportation of perishable hazardous material, including radiopharmaceuticals and other medical products, that may require timely delivery due to life-threatening situations;

“(B) the means by which—

“(i) noncompliant packages that present an imminent hazard are placed out-of-service until the condition is corrected; and

“(ii) noncompliant packages that do not present a hazard are moved to their final destination;

“(C) appropriate training and equipment for inspectors; and

“(D) the proper closure of packaging in accordance with the hazardous material regulations.”.

(2) Finalizing Regulations—In accordance with section 5103(b)(2) of title 49, United States Code, not later than 1 year after the date of enactment of this Act, the Secretary shall take all actions necessary to finalize a regulation under paragraph (1) of this subsection.

126 Stat. at 836-7.

As described further below, we believe that the Department's current rules that were previously established through notice and comment rulemaking and existing policies and operating procedures thoroughly address the congressional mandates to address certain hazmat transportation matters. In PHM-7, the Department established procedural regulations for opening packages, removing packages from transportation, and closing packages. These regulations include the definition of key terms, including perishable hazardous material. The regulations address how the Department's agents will handle non-compliant packages that present an imminent hazard and those that do not. Moreover, the rules address when and how the Department's agents will open a package. And, if an agent opens a package, there are procedural rules for closing the package and ensuring its safe resumption of transportation, if applicable. In addition, the Department developed an internal operations manual for training and use by its hazmat inspectors and investigators across all modes of transportation. The operations manual's guidance is intended to target and manage the use of the enhanced inspection and enforcement authority in a uniform and consistent manner within the Department. At this time, we do not have any data or other information that indicate the rules, policies, andoperating procedures currently in place are inadequate or that additional regulations are necessary.

III. Summary of Proposals in This NPRM

In MAP-21 Congress directed the Secretary to address certain transportation matters related to the Department's enhanced inspection, investigation, and enforcement authority. The relevant MAP-21 mandates for this rulemaking are:

• Notice of enforcement measures;

• The safe and expeditious resumption of transportation of perishable hazardous material, including radiopharmaceuticals and other medical products that may require timely delivery due to life-threatening situations;

• The means by which non-compliant packages that present an imminent hazard are placed out-of- service until the condition is corrected;

• The means by which non-compliant packages that do not present a hazard are moved to their final destination;

• Appropriate training and equipment for inspectors; and

• The proper closure of packaging in accordance with the hazardous material regulations.

We are proposing in this rulemaking, as described further below, to clarify the Department's position with respect to perishable hazardous material, by amending the opening of packages provision of the Department's hazardous materials procedural regulations for the opening of packages, emergency orders, and emergency recalls. The amendment recognizes the special characteristics and handling requirements of perishable hazardous material by clarifying that an agent will stop or open a package containing a perishable hazardous material only after the agent has utilized appropriate alternatives. We are also proposing to codify the statutory notification requirement in HMTSIA by incorporating into the regulations the Department's current notification procedures from the operations manual that was developed in conjunction with the PHM-7 final rule. Finally, we are proposing to add a new provision to address appropriate equipment for inspectors.

For the remaining mandates to address certain matters related to the Department's enhanced inspection, investigation, and enforcement authority, we are proposing no additional regulatory changes. We believe that the Department's current rules that were previously established through notice and comment rulemaking and existing policies and operating procedures thoroughly address the hazmat transportation matters identified by Congress. For instance, in a prior rulemaking, the Department established, in Part 109, procedural regulations for opening packages, removing packages from transportation, and closing packages. These regulations include the definition of key terms, including perishable hazardous material. The regulations address how the Department's agents will handle non-compliant packages that present an imminent hazard and those that do not. Moreover, the rules address when and how the Department's agents will open a package. And, if an agent opens a package, there are procedural rules for closing the package and ensuring its safe resumption of transportation, if applicable. In addition, the Department developed an internal operations manual for training and use by its hazmat inspectors and investigators across all modes of transportation. The operations manual's guidance is intended to target and manage within the Department the use of the enhanced inspection and enforcement authority in a uniform and consistent manner. At this time, we do not have any data or other information that indicate the rules, policies, and operating procedures currently in place are inadequate or that additional rulemaking is necessary.

Notice of Enforcement Measures

In PHM-7, we established procedures to implement the enhanced inspection, investigation, and enforcement authority conferred on the Secretary through HMTSSRA. In the NPRM for that rule, in response to commenters' concerns about notifying offerors and consignees about a possible delay in arrival, we agreed that all parties responsible for a shipment that is opened or removed from transportation need to be notified of the action taken. We said that “DOT inspectors will be required to communicate the findings made and enforcement measures taken to the appropriate offeror, recipient, and carrier of the package . . .”. 73 FR 57288. In the final rule, we outlined how we would notify affected parties when an agent exercises one of the new authorities. 76 FR 11580. In the preamble to the final rule, we explained that the notification procedures would be incorporated into the Department's joint operations manual. Id. The notification procedures that we developed for the joint operations manual address situations where an agent may exercise a 49 CFR Part 109 authority for a package that is in transit. In this case, the person in possession of the package, such as a carrier, may not be the person responsible for the package, i.e. the offeror. Therefore, we set out separate procedures for immediately notifying the person in possession and the original offeror. Generally, the agent will verbally notify the person in possession. If the person in possession is not the original offeror, the agent will also take reasonable measures to notify the original offeror.

In MAP-21 Congress added a notification requirement to the Department's inspection and investigation authority. Specifically, Section 5121(c)(1) was amended to include new subparagraph (G). Section 5121(c)(1) now reads:

“(c) Inspections and investigations.—

(1) In general.—A designated officer, employee, or agent of the Secretary—

(i) his or her decision to exercise his or her authority under paragraph (1);

(ii) any findings made; and

(iii) any actions being taken as a result of a finding of noncompliance.

126 Stat. at 836-7.

We are proposing in this rulemaking to codify this statutory notification requirement by incorporating into the regulations the Department's current notification procedures from the joint operations manual. As discussed above, the joint operations manual includes procedures and guidance to agents for providing notice of enforcement measures taken under 49 CFR part 109. The procedures in the manual are comprehensive and comport with the statutory mandate. As such, under this proposal, a new notification section will be added to part 109, subpart B of 49 CFR. It will require that an agent, after exercising a 49 CFR part 109 inspection or investigation authority, immediately take reasonable measures to notify the appropriate person of the reason for the action being taken, the results of any preliminary investigation including apparent violations of the HMR, and any further action that may be warranted.

The Safe and Expeditious Resumption of Transportation of Perishable Hazardous Material

We addressed the opening, reclosing, and resumption of transportation of perishable hazardous material in a previous rulemaking. In PHM-7, we defined “perishable hazardous material” as “a hazardous material that is subject to significant risk of speedy decay, deterioration, or spoilage, orhazardous materials consigned for medical use, in the prevention, treatment, or cure of a disease or condition in human beings or animals where expeditious shipment and delivery meets a critical medical need.” 76 FR 11592 (codified at 49 CFR § 109.1). Further, we established procedures for reclosing a package containing a perishable hazardous material and its safe and expeditious resumption of transportation. Section 109.13 contains the requirements for the closing of packages and the safe resumption of transportation, including a specific requirement pertaining to perishable hazardous material.

We believe the definition of perishable hazardous material and the rules, current procedures, and guidance already developed for reclosing packages, sufficiently address Congress' concern and the need for expeditious treatment of these types of materials. We also note that in the Department's joint operations manual, we have significantly restricted an agent's ability to handle or open a package containing perishable hazardous material. For example, an agent must have been trained in the handling of the specific material and may only open a perishable hazardous material package in a designated facility, if required, and have all safety equipment, handling equipment, and materials to properly close the package. Notwithstanding, in order to clarify the Department's position with respect to perishable hazardous material, we are proposing to amend the opening of packages provision of the Department's hazardous materials procedural regulations for the opening of packages, emergency orders, and emergency recalls. The amendment recognizes the special characteristics and handling requirements of perishable hazardous material by clarifying that an agent will stop or open a package containing a perishable hazardous material only after the agent has utilized appropriate alternatives.

In consideration of the special characteristics and handling requirements of perishable hazardous material, we are proposing to establish a Department policy that its agents will not intentionally open packages containing perishable hazardous material unless a compelling safety need exists. However, in accordance with our current procedures, an agent may stop, remove, or have a package containing these types of materials transported to a facility for further examination and analysis. We solicit comments from the public whether excluding these types of materials is appropriate.

Handling of non-compliant packages

In MAP-21 Congress mandated that the Department take all actions necessary to finalize a regulation addressing the means by which non-compliant packages are processed when an agent exercises an authority under Part 109. Specifically, Section 5121(e) was amended to include new paragraph (3). The relevant amendment to Section 5121(e) includes the following language:

(3) Matters to be addressed.—The regulations issued under this subsection shall address—

(B) the means by which—

(i) noncompliant packages that present an imminent hazard are placed out-of-service until the condition is corrected; and

(ii) noncompliant packages that do not present a hazard are moved to their final destination.

126 Stat. at 837.

The Department's procedural rules for opening of packages, emergency orders, and emergency recalls are in 49 CFR part 109. These procedures address the means by which a non-compliant package that is found to be an imminent hazard is placed out-of-service. Specifically, in § 109.13, if an imminent hazard is found to exist after an agent opens a package, the operating administration's authorized official may issue an out-of-service order prohibiting the movement of the package. 49 CFR 109.13(b). The package must be removed from transportation until it is brought into compliance. Id. An out-of-service order is a type of emergency order. In 49 CFR, subpart C of part 109 contains the procedural regulations for issuing an out-of-service emergency order, including procedures for administrative review, reconsideration, and appellate review of an emergency order. Furthermore, the joint operations manual provides inspection personnel with step-by-step procedures and additional guidance for issuing an out-of-service order. For example, at least two levels of review and consultation with the operating administration's legal office is required before an emergency order can be issued. Moreover, the operations manual addresses documentation requirements, notification, service, publication, and termination requirements.

Regarding non-compliant packages that do not present a hazard, it is important to note that a non-compliant package may not continue in transportation until all identified non-compliant issues are resolved. 49 CFR 109.13(d). In the PHM-7 final rule where we established the enhanced enforcement procedures, we stated that for a non-compliant package, the agent would not close the package and that there is no obligation to bring that package into compliance. 76 FR 11587. Further, we stated, “[t]he Department's operating administrations will not be responsible for bringing an otherwise non-compliant package into compliance and resuming its movement in commerce.” Id. We reasoned that if the package does not conform to the HMR at the time of inspection, the act that a DOT official opened it in the course of an inspection or investigation will not make DOT or its agent responsible for bringing the package into compliance. Id.

In light of the above, we have already fulfilled the applicable mandate for the handling of non-compliant packages and no further action is required.

Appropriate Training and Equipment for Inspectors

Congress recognized that “[t]here is currently no uniform training standard for hazardous materials (‘hazmat') inspectors and investigators.” H. Conf. Rep. No. 112-557 at 610 (2012). To address this problem, it mandated in MAP-21 that the Secretary establish uniform performance standards for training hazmat inspectors and investigators no later than eighteen months from the date of enactment of the Act. 126 Stat. at 836. The mandate authorizes the development of guidelines for hazmat inspector and investigator qualifications; best practices and standards for hazmat inspector and investigator training programs; and standard protocols to coordinate investigation efforts among Federal, State, and local jurisdictions on accidents or incidents involving the transportation of hazardous material. In order to achieve a uniform hazmat training standard, Congress required that the standards, protocols, and guidelines developed would be mandatory to the Department's multimodal personnel conducting hazmat enforcement inspections and investigations.

Additionally, Congress mandated that the Department take all actions necessary to finalize a regulation, no later than one year from the date of enactment of the Act, addressing appropriate training and equipment for inspectors when exercising an authority under 49 CFR Part 109. Specifically, Section 5121(e) was amended to include new paragraph (3). The relevantamendment to Section 5121(e) includes the following language:

(3) Matters to be addressed.—The regulations issued under this subsection shall address—

(C) appropriate training and equipment for inspectors; and

126 Stat. at 837

Although the MAP-21 mandates here are training related, it is evident that the development of a uniform training scheme is essential because it will establish the foundation upon which future training for hazmat inspectors and investigators is expected to follow. As such, it is premature to require the Department to promulgate enforcement procedural regulations for hazmat training and equipment before the Department has had the opportunity to develop uniform performance training standards. This approach does not appear to be the best way to meet Congress' objective to ensure that all hazmat inspectors and investigations receive uniform and standardized training. It would be more appropriate for the Department to establish the uniform performance training standards, best practices, and protocols before it develops additional training regulations for its hazmat personnel. This would ensure that new training rules are consistent with the uniform training scheme.

Notwithstanding, we understand that proper training of inspectors and investigators is essential to ensure that the enhanced enforcement authority is used effectively and judiciously. In the NPRM for PHM-7, we explained that the operating administrations responsible for enforcement of the HMR—PHMSA, FMCSA, FAA, and FRA—worked together to develop the rule and a joint operations manual. 73 FR 57285. We further explained that the proposed regulations set out a framework for the procedures the operating administrations will employ when conducting inspections or investigations, thus ensuring consistency in approaches and enforcement measures among modes of transportation. Moreover, we stated that the final rule, implemented with the guidance of an operational manual, would ensure that this authority was properly used. Id. We expressed our confidence in this approach because with the cooperation of the operating administrations in the development of the rule, and the accompanying operations manual, it meant that all Department inspectors and investigators would have the same general training and modal specific instruction. 73 FR 57288.

Regarding equipment, we are proposing to add a new provision to address appropriate equipment for inspectors when they exercise a Part 109 authority. Under this proposal, a new equipment section will be added to new Subpart D—Equipment, requiring an agent to use the appropriate safety, handling, and other equipment authorized by his or her operating administration's equipment requirements for hazardous material inspectors and investigators.

Consequently, we do not believe that we should develop rules for appropriate training in this rulemaking. Instead, we advocate addressing any performance standards as part of the larger hazardous materials performance standard development activity currently underway. In the meantime, we believe the existing rules in 49 CFR Part 109 and the attendant operational procedures in the joint operations manual, as well as each operating administration's specific guidance for its enforcement staff, sufficiently address the training concern identified by Congress in the MAP-21 directive. Therefore, PHMSA does not believe that further action is necessary at this time.

The Proper Closure of Packaging in Accordance With HMR

In MAP-21 Congress mandated that the Department take all actions necessary to finalize a regulation addressing “the proper closure of packaging in accordance with the hazardous material regulations.” 126 Stat. at 837.

In PHM-7 we addressed reclosing of packages opened under the enhanced inspection, investigation, and enforcement authority. In several of the comments that we received about that rulemaking, the regulated community raised concerns about how we were going to reclose packages after they have been opened under the new authority. In the NPRM, we responded by stating that the Department was developing internal operational procedures and guidance to address the proper closure of packaging in accordance with the HMR. We also solicited further comment from the public on the factors that should be considered in the development of these procedures and guidance. 73 FR 57286. However, we also stated that an agent's obligation to reclose a package only arose if, after opening the package, an imminent hazard was found not to exist and the package otherwise complied with the HMR. 76 FR 11587. More importantly, we also said that the Department's operating administrations would not be responsible for bringing an otherwise non-specification or non-compliant package into compliance and resuming its movement in commerce. Id. If the package did not comply with the HMR the fact that a DOT official opened it in the course of an inspection or investigation would not make DOT or its inspector responsible for bringing the package into compliance. Id. In the final rule, we significantly revised the new rule for closing packages to cover each possible re-closure scenario: no imminent hazard found; imminent hazard found; package does not contain a hazardous material; and package contains a hazardous material not in compliance with the HMR. Id. Further, we stated that the inspector would only be required to reclose a package in accordance with the packaging manufacturer's closure instructions or other appropriate method when a package was opened and no imminent hazard was found. Id. In the joint operations manual we developed procedures for properly closing a package. These procedures include steps for reclosing a package. It also includes additional requirements and procedures to complete the re-closure process, including methods to thoroughly document the activities performed.

In light of the above, we believe the existing requirements in 49 CFR Part 109 for closing opened packages (Section 109.13) and the attendant operational procedures in the joint operations manual sufficiently address the matter identified by Congress in the MAP-21 directive. Therefore, no further action is necessary.

IV. Summary Review of Proposed Amendments

We are proposing to amend the opening of packages provision of the Department's hazardous materials procedural regulations for the opening of packages, emergency orders, and emergency recalls. The amendment recognizes the special characteristics and handling requirements of perishable hazardous material by clarifying that an agent will stop or open a package containing a perishable hazardous material only after the agent has utilized appropriate alternatives. We are also proposing to add a notification provision to 49 CFR under Part 109 Subpart B—Inspections and Investigations. The provision will provide for the immediate and reasonable notification of enforcement action taken by an inspector orinvestigator whenever he or she exercises one of the inspection and investigation authorities under 49 CFR Part 109, Subpart B, which includes the opening of packages; removing a package and related packages in a shipment from transportation; directing a package to be transported to a facility for examination and analysis; and authorizing properly qualified personnel to assist in activities conducted under Subpart B. The notice will include the reason for the action being taken, the results of any preliminary investigation including apparent violations of the HMR, and any further action that may be warranted. Finally, we are proposing to add a new provision to address appropriate equipment for inspectors when they exercise a Part 109 authority. The new equipment section will be added to 49 CFR under new Subpart D—Equipment. The provision will require an agent to use the appropriate safety, handling, and other equipment authorized by his or her operating administration's equipment requirements for hazardous material inspectors and investigators.

V. Regulatory Analyses and NoticesA. Statutory/Legal Authority for This Rulemaking

This notice of proposed rulemaking (NPRM) is published under the authority of the Federal Hazardous Materials Transportation Law, 49 U.S.C. § 5101et seq.Section 5103(b) authorizes the Secretary to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. This NPRM would revise PHMSA's procedural regulations for opening of packages, emergency orders, and emergency recalls to address certain matters identified in the Hazardous Materials Transportation Safety Act of 2012 related to Department's enhanced inspection, investigation, and enforcement authority. The NPRM carries out the statutory mandate and clarifies DOT's role and responsibilities in ensuring that hazardous materials are being safely transported and promoting the regulated community's understanding and compliance with regulatory requirements applicable to specific situations and operations.

B. Executive Order 13610, Executive Order 13563, Executive Order 12866, and DOT Regulatory Policies and Procedures

This NPRM is not considered a significant regulatory action under section 3(f) Executive Order 12866 and, therefore, was not reviewed by the Office of Management and Budget (OMB). The proposed rule is not considered a significant rule under the Regulatory Policies and Procedures order issued by the U.S. Department of Transportation (44 FR 11034).

Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review that were established in Executive Order 12866 Regulatory Planning and Review of September 30, 1993. Executive Order 13563, issued January 18, 2011, notes that our nation's current regulatory system must not only protect public health, welfare, safety, and our environment but also promote economic growth, innovation, competitiveness, and job creation.2Further, this executive order urges government agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. In addition, federal agencies are asked to periodically review existing significant regulations, retrospectively analyze rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and modify, streamline, expand, or repeal regulatory requirements in accordance with what has been learned.

Executive Order 13610, issued May 10, 2012, urges agencies to conduct retrospective analyses of existing rules to examine whether they remain justified and whether they should be modified or streamlined in light of changed circumstances, including the rise of new technologies.3

3Seehttp://www.gpo.gov/fdsys/pkg/FR-2012-05-14/pdf/2012-11798.pdf

By building off of each other, these three Executive Orders require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.”

This proposed rule revises 49 CFR part 109, which contains regulations on DOT inspection and investigation procedures. These regulations are not part of the HMR, which govern the transportation of hazmat, thus they do not carry any additional compliance requirements or costs for entities that must comply with the HMR. It is possible, however, that some carriers or shippers, who in the absence of this rule would have refused to open a package when requested, may experience delays that they would not have otherwise faced. DOT is not aware of any cases of shippers or carriers refusing to open packages and so anticipates that these costs will be minimal.

C. Executive Order 13132

This proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). 49 U.S.C. 5125(h) provides that the preemption provisions in Federal hazardous material transportation law do “not apply to any procedure . . . utilized by a State, political subdivision of a State, or Indian tribe to enforce a requirement applicable to the transportation of hazardous material.” Accordingly, this proposed rule has no preemptive effect on State, local, or Indian tribe enforcement procedures and penalties, and preparation of a federalism assessment is not warranted.

D. Executive Order 13175

This NPRM has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this NPRM does not significantly or uniquely affect the communities of the Indian tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

The Regulatory Flexibility Act (5 U.S.C. 601et seq.) requires an agency to review regulations to assess their impact on small entities unless the agency determines that a rule is not expected to have significant impact on a substantial number of small entities. I hereby certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. This proposed rule applies to offerors and carriers of hazardous materials, some of which are small entities; however, there will not be any economic impact on any person who complies with Federal hazardous materials law and the regulations and orders issued under that law.

Potentially affected small entities.The provisions in this proposed rule will apply to persons who perform, or cause to be performed, functions related to the transportation of hazardous materials in transportation in commerce. This includes offerors of hazardous materials and persons in physical control of a hazardous material during transportation in commerce. Suchpersons may primarily include motor carriers, air carriers, vessel operators, rail carriers, temporary storage facilities, and intermodal transfer facilities. Unless alternative definitions have been established by the agency in consultation with the Small Business Administration, the definition of “small business” has the same meaning as under the Small Business Act (15 CFR parts 631-657c). Therefore, since no such special definition has been established, PHMSA employs the thresholds (published in 13 CFR 121.201) of 1,500 employees for air carriers (NAICS Subgroup 481), 500 employees for rail carriers (NAICS Subgroup 482), 500 employees for vessel operators (NAICS Subgroup 483), $18.5 million in revenues for motor carriers (NAICS Subgroup 484), and $18.5 million in revenues for warehousing and storage companies (NAICS Subgroup 493). Of the approximately 116,000 entities to which this proposed rule would apply (104,000 of which are motor carriers), we estimate that about 90 percent are small entities.

Potential cost impacts.This proposed rule revises 49 CFR Part 109, which contains regulations on DOT inspection and investigation procedures. These regulations are not part of the HMR, which govern the transportation of hazmat, thus they do not carry any additional compliance requirements or costs for entities that must comply with the HMR. It is possible, however, that some carriers or shippers, who in the absence of this rule would have refused to open a package when requested, may experience delays that they would not have otherwise faced. DOT is not aware of any cases of shippers or carriers refusing to open packages and so anticipates that these costs will be minimal.

Alternate proposals for small business.Because this proposed rule addresses a Congressional mandate, we have limited latitude in defining alternative courses of action. The option of taking no action would be both inconsistent with Congress' direction and undesirable from the standpoint of safety and enforcement. Failure to implement the new authority will perpetuate the problem of undeclared hazardous material shipments and resulting incidents or releases. It will also leave PHMSA and other operating administrations without an effective plan to abate an imminent safety hazard.

F. Paperwork Reduction Act

PHMSA has analyzed this final rule in accordance with the Paperwork Reduction Act of 1995 (PRA). The PRA requires Federal agencies to minimize the paperwork burden imposed on the American public by ensuring maximum utility and quality of federal information, ensuring the use of information technology to improve government performance, and improving the federal government's accountability for managing information collection activities. This final rule contains no new information collection requirements subject to the PRA.

G. Regulation Identifier Number (RIN)

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

H. Unfunded Mandates Reform Act of 1995

This proposed rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $141.3 million or more to either state, local or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the rule.

I. Environmental Assessment

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), and implementing regulations by the Council on Environmental Quality (40 CFR part 1500) require Federal agencies to consider the consequences of Federal actions and prepare a detailed statement on actions that significantly affect the quality of the human environment.

The purpose of this rulemaking is to amend the Department's existing enforcement procedures to (1) to clarify the Department's position with respect to perishable hazardous material, by amending the opening of packages provision; (2) provide notice of enforcement measures to affected parties; and (3) address appropriate equipment for inspectors. Because this NPRM addresses Congressional mandates, we have limited latitude in defining alternative courses of action. The option of taking no action would be both inconsistent with Congress' direction and undesirable from the standpoint of safety and enforcement. These inspection and enforcement procedures will not change the current inspection procedures for DOT, but will augment DOT's existing enforcement procedures and allow the Department to respond immediately and effectively to conditions or practices that pose serious threat to life, property, or the environment. PHMSA has initially determined that the implementation of the proposed rule will not have any significant impact on the quality of the human environment. PHMSA, however, invites comments about environmental impacts that the proposed rule might pose.

J. Privacy Act

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in theFederal Registerpublished on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) which may be viewed at:http://www.gpo.gov/fdsys/pkg/FR-2000-04-11/pdf/00-8505.pdf.

List of Subjects in 49 CFR Part 109

Inspections and investigations. Equipment.

In consideration of the foregoing, 49 CFR Chapter I is proposed to be amended as follows:

PART 109—DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS PROCEDURAL REGULATIONS FOR OPENING OF PACKAGES, EMERGENCY ORDERS, AND EMERGENCY RECALLS1. The authority citation for part 109 is revised to read as follows:Authority:

2. In § 109.5, a new paragraph (b) is added to read as follows:§ 109.5Opening of packages.

(b)Perishable hazardous material.To ensure the expeditious transportation of a package containing a perishable hazardous material, an agent will utilize appropriate alternatives before exercising an authority under paragraph (a).

3. Section 109.16 is added to read as follows:§ 109.16Notification of Enforcement Measures.

In addition to the notification requirements in § 109.7, an agent, after exercising an authority under thisSubpart, will immediately take reasonable measures to notify the offeror and the person in possession of the package, providing the reason for the action being taken, the results of any preliminary investigation including apparent violations of subchapter C of this chapter, and any further action that may be warranted.

When an agent exercises an authority under Subpart B, the agent shall use the appropriate safety, handling, and other equipment authorized by his or her operating administration's equipment requirements for hazardous material inspectors and investigators.

Issued in Washington, DC, on May 13, 2013, under authority delegated in 49 CFR Part 106.Magdy El-Sibaie,Associate Administrator for Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration.[FR Doc. 2013-12123 Filed 5-21-13; 8:45 am]BILLING CODE 4910-60-P7899Wednesday, May 22, 2013NoticesAGENCY FOR INTERNATIONAL DEVELOPMENTNotice of Cancellation of May 17 President's Global Development Council MeetingAGENCY:

United States Agency for International Development.

ACTION:

Notice of cancellation of meeting.

SUMMARY:

Pursuant to the Federal Advisory Committee Act, notice is hereby given of cancellation of the meeting of the President's Global Development Council (GDC) on Friday, May 17, 2013 in the Eisenhower Executive Office Building, South Court Auditorium, Pennsylvania Avenue and 17th Street NW., which was published in theFederal Registeron May 9, 2013, 78 FR 27178.

This notice is being cancelled due to exceptional circumstances of coordinating high-level schedules. A new meeting date and time will be forthcoming.

USAID Administrator Rajiv Shah will make opening remarks, followed by a panel discussion on the creation of a Feed the Future Civil Society Action Plan, and an opportunity for public comment. A draft agenda will be forthcoming on the ACVFA Web site athttp://www.usaid.gov/who-we-are/organization/advisory-committee.

Stakeholders

The meeting is free and open to the public. Persons wishing to attend should register online athttp://www.usaid.gov/who-we-are/organization/advisory-committee/get-involved.

The Humboldt Resource Advisory Committee (RAC) will meet in Eureka, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub.L. 112-141) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. The meetings are open to the public. The purpose of the meetings are to review prior year project's progress. Should the Secure Rural Schools Act be reauthorized, the purpose of the meetings will also be to review and recommend project proposals.

DATES:

The meetings will be held June 10, 2013; July 8, 2013 and July 22, 2013. All meetings will begin at 5:00 p.m.

ADDRESSES:

The meetings will be held at the Six Rivers National Forest Office, 1330 Bayshore Way, Eureka, California 95501. Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Six Rivers National Forest Supervisor's Office, 1330 Bayshore Way, Eureka, CA. 95501. Please call ahead to 707-442-1721 to facilitate entry into the building to view comments.

Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

SUPPLEMENTARY INFORMATION:

The following business will be conducted: Review prior year project's progress. Should the Secure Rural Schools Act is reauthorized, the purpose of the meetings will also be to review and recommend project proposals.

Contact Committee Coordinator listed above for meeting agenda information. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by 5 days prior to meeting date to be scheduled on the agenda. Written comments and requests for time for oral comments must be sent to RAC Committee Coordinator, 1330 Bayshore Way, Eureka, CA. 95501 or by email tohwright02@fs.fed.us,or via facsimile to 707-445-8677. A summary of the meeting will be posted athttp://www.fs.usda.gov/main/srnf/homewithin 21 days of the meeting.

Meeting Accommodations:If you require sign language interpreting, assistive listening devices or other reasonable accommodation please request this in advance of the meeting by contacting the person listed in the section titledFOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

The Del Norte County Resource Advisory Committee (RAC) will meet in Crescent City, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 112-141) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. The meetings are open to the public. The purpose of the meetings are to review prior year project's progress. Should the Secure Rural Schools Act be reauthorized, the purpose of the meetings will also be to review and recommend project proposals.

DATES:

The meetings will be held June 5, 2013; July 16, 2013; and July 22, 2013. All meetings will begin at 6:00 p.m.

ADDRESSES:

The meetings will be held at the Del Norte County Unified School District, Redwood Room, 301 West Washington Boulevard, Crescent City CA 95531. Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Six Rivers National Forest Supervisor's Office, 1330 Bayshore Way, Eureka, CA. 95501. Please call ahead to 707-442-1721 to facilitate entry into the building to view comments.

FOR FURTHER INFORMATION CONTACT:

Lynn Wright, Committee Coordinator, 707-441-3562; emailhwright02@fs.fed.us.Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday. Please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accomodation for access to the facility or procedings by contacting the person listedFOR FURTHER INFORMATION CONTACT.

SUPPLEMENTARY INFORMATION:

The purpose of the meetings are to review prior year project's progress. If the Secure Rural Schools Act is reauthorized, the purpose of the meetings will also be to review and recommend project proposals. Contact Committee Coordinator listed above for meeting agenda information. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by 5 days prior to meeting date to be scheduled on the agenda. A summary of the meeting will be posted athttp://www.fs.usda.gov/main/srnf/homewithin 21 days of the meeting.

Meeting Accommodations:If you require sign language interpreting, assistive listening devices or other reasonable accommodation please request this in advance of the meeting by contacting the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS) invites comments on this information collection for which RUS intends to request approval from the Office of Management and Budget (OMB).

The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for extension.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Michele Brooks, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, STOP 1522, Room 5162, South Building, 1400 Independence Ave. SW., Washington, DC 20250-1522. FAX: (202) 720-4120.michele.brooks@wdc.usda.gov.

Title:Weather Radio Transmitter Grant Program.

OMB Control Number:0572-0124.

Type of Request:Revision of a currently approved information collection.

Abstract:The National Weather Service operates an All Hazards Early Warning System that alerts people in areas covered by its transmissions of approaching dangerous weather and other emergencies. The National Weather Service can typically provide warnings of specific weather dangers up to fifteen minutes prior to the event. At present, this system covers all major metropolitan areas and many smaller cities and towns; however, many rural areas lack NOAA Weather Radio coverage. The Rural Utilities Service's Weather Radio Transmitter Grant Program finances the installation of new transmitters to extend the coverage of the National Oceanic and Atmospheric Administration's Weather Radio system (NOAA Weather Radio) in rural America thereby promoting public safety and awareness. The President of the United States and the United States Congress have made $5 million in grant funds available to facilitate the expansion of NOAA Weather Radio system coverage into rural areas that are not covered or are poorly covered at this time. This grant program will continue to provide grant funds, on an expedited basis, for use in rural areas and communities of 50,000 or less inhabitants. Grant funds are available immediately and applications will be processed on a first-come, first-served basis until the appropriation is used in its entirety. Grant funds are used to purchase and install NOAA Weather Radio transmitters and antennas that are combined with donated tower space and other site resources to establish new rural NOAA Weather Radio transmitters. Eligible applicants must be non-profit corporations or associations (including Rural Development Utilities Programs electric and telecommunications borrower cooperatives), units of local or state government, or Federally-recognized Indian tribes.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 5 hours per response.

The Bureau of the Census (U.S. Census Bureau) is giving notice of a meeting of the Federal Economic Statistics Advisory Committee (FESAC). The Committee will advise the Directors of the Economics and Statistics Administration's (ESA) two statistical agencies, the Bureau of Economic Analysis (BEA) and the Census Bureau, and the Commissioner of the Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. Last minute changes to the agenda are possible, which could prevent giving advance public notice of schedule adjustments.

DATES:

June 14, 2013. The meeting will begin at approximately 9:00 a.m. and adjourn at approximately 4:30 p.m.

ADDRESSES:

The meeting will be held at the U.S. Census Bureau Conference Center, 4600 Silver Hill Road, Suitland, MD 20746.

FOR FURTHER INFORMATION CONTACT:

Barbara K. Atrostic, Designated Federal Official, Department of Commerce, U.S. Census Bureau, Research and Methodology Directorate, Room 2K267, 4600 Silver Hill Road, Washington, DC 20233, telephone 301-763-6442, email:Barbara.kathryn.atrostic@census.gov.For TTY callers, please call the Federal Relay Service (FRS) at 1-800-877-8339 and give them the above listed number you would like to call. This service is free and confidential.

SUPPLEMENTARY INFORMATION:

Members of the FESAC are appointed by the Secretary of Commerce. The Committee advises the Directors of the BEA, the Census Bureau, and the Commissioner of the Department of Labor's BLS, on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. The Committee is established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2).

The meeting is open to the public, and a brief period is set aside for public comments and questions. Persons with extensive questions or statements must submit them in writing at least three days before the meeting to the Designated Federal Official named above. If you plan to attend the meeting, please register by Monday, June 10, 2013. You may access the online registration form with the following link:http://www.regonline.com/fesac_june2013_meeting.Seating is available to the public on a first-come, first-served basis.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should also be directed to the Designated Federal Official as soon as known, and preferably two weeks prior to the meeting.

Due to increased security and for access to the meeting, please call 301-763-9906 upon arrival at the Census Bureau on the day of the meeting. A photo ID must be presented in order to receive your visitor's badge. Visitors are not allowed beyond the first floor.

On January 17, 2013, the Port of Bellingham, grantee of FTZ 129, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of T.C. Trading Company, Inc., within Subzone 129B, in Blaine Washington.

The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in theFederal Registerinvitingpublic comment (78 FR 7395, 02/01/2013). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

The Puerto Rico Trade and Export Company, grantee of FTZ 61, submitted a notification of proposed production activity to the FTZ Board on behalf of Janssen Ortho LLC (Janssen), located in Gurabo, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on April 29, 2013.

A separate application for subzone status at the Janssen facility was submitted and will be processed under Section 400.31 of the FTZ Board's regulations. The facility is used for the production of various prescription and over-the-counter pharmaceutical products. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products listed in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

Production under FTZ procedures could exempt Janssen from customs duty payments on the foreign status components used in export production. On its domestic sales, Janssen would be able to choose the duty rates during customs entry procedures that apply to various prescription and over-the-counter pharmaceutical products, including: Anti-cancer; anti-diabetic and immunosuppressive medicaments; analgesics; antipyretic and anti-inflammatory agents; and, cough and cold preparations (duty free) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign status production equipment.

Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is July 1, 2013.

A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible viawww.trade.gov/ftz.

An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Erie-Western Pennsylvania Port Authority, grantee of FTZ 247, requesting special-purpose subzone status for the facility of GE Transportation, located in Lawrence Park Township, Pennsylvania. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on May 16, 2013.

The proposed subzone (350 acres) is located at 2901 East Lake Road, Lawrence Park Township, Erie County, Pennsylvania. No production activity has been requested at this time, but the company has indicated that a notification of proposed production activity will be submitted. Any such notifications will be published separately for public comment. The proposed subzone would be subject to the existing activation limit of FTZ 247.

In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is July 1, 2013. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to July 16, 2013.

A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible viawww.trade.gov/ftz.

An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Erie-Western Pennsylvania Port Authority, grantee of FTZ 247, requesting special-purpose subzone status for the facility of GE Transportation, located in Grove City, Pennsylvania. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on May 16, 2013.

The proposed subzone (49 acres) is located at 1503 West Main Street Ext., Grove City, Mercer County, Pennsylvania. No production activity has been requested at this time, but thecompany has indicated that a notification of proposed production activity will be submitted. Any such notifications will be published separately for public comment. The proposed subzone would be subject to the existing activation limit of FTZ 247.

In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is July 1, 2013. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to July 16, 2013.

A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible viawww.trade.gov/ftz.

On September 7, 2012, the United States Court of Appeals for the Federal Circuit (CAFC) issued a decision not in harmony with the final determination of the Department of Commerce (the Department) that stainless steel plate in coils (SSPC) from Belgium, South Africa, and Taiwan with a nominal thickness of 4.75 millimeters (mm), but an actual thickness of less than 4.75 mm, is subject to theAD and CVD Orderson SSPC.1On March 26, 2013, the United States Court of International Trade (CIT) sustained the Department's results of redetermination issued in accordance with the CAFC's decision inArcelorMittal.2Those results of redetermination found that SSPC with an actual thickness of less than 4.75 mm, regardless of its nominal thickness, is not subject to theAD and CVD Orderson SSPC.3Consistent with the CAFC's decision inTimken Co.v.United States,893 F.2d 337 (Fed. Cir. 1990) (Timken), as clarified byDiamond Sawblades Mfrs. Coalitionv.United States,626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades), the Department is notifying the public that the final CAFC judgment in this case is not in harmony with the Department's final determination and is amending its Final Scope Ruling concerning SSPC with a nominal thickness of 4.75 mm, but an actual thickness of less than 4.75 mm.4

1See ArcelorMittal Stainless Belgium N.V.v.United States,694 F.3d 82 (Fed. Cir. 2012) (ArcelorMittal). Because the description of the scopes in the multiple SSPC orders is identical and given the nature of the inquiry, the Department has considered it appropriate pursuant to 19 CFR 351.225(m) to conduct a single inquiry and issue a single scope ruling that applies to all such orders.See Notice of Amended Final Determinations: Stainless Steel Plate in Coils from Belgium and South Africa; and Notice of Countervailing Duty Orders: Stainless Steel Plate in Coils from Belgium, Italy and South Africa,64 FR 25288 (May 11, 1999);Antidumping Duty Orders; Certain Stainless Steel Plate in Coils From Belgium, Canada, Italy, the Republic of Korea, South Africa, and Taiwan,64 FR 27756 (May 21, 1999);Notice of Amended Antidumping Duty Orders; Certain Stainless Steel Plate in Coils From Belgium, Canada, Italy, the Republic of Korea, South Africa, and Taiwan,68 FR 11520 (March 11, 2003); andNotice of Amended Countervailing Duty Orders; Certain Stainless Steel Plate in Coils From Belgium, Italy, and South Africa,68 FR 11524 (March 11, 2003) (collectively,AD and CVD Orders). The antidumping orders on SSPC from Italy and South Korea and the countervailing duty order on Belgium were revoked effective August 31, 2011, November 16, 2011, and July 18, 2010, respectively.See Stainless Steel Plate in Coils From Italy: Revocation of Antidumping Duty Order,76 FR 54207 (August 31, 2011);Notice of Implementation of Determination Under Section 129 of the Uruguay Round Agreements Act and Revocation of the Antidumping Duty Order on Stainless Steel Plate in Coils From the Republic of Korea; and Partial Revocation of the Antidumping Duty Order on Stainless Steel Sheet and Strip in Coils From the Republic of Korea,76 FR 74771 (December 1, 2011);Stainless Steel Plate in Coils from Belgium: Final Results of Full Sunset Review and Revocation of the Countervailing Duty Order,76 FR 25666 (May 5, 2011).

Having received a scope inquiry request from ArcelorMittal Stainless Belgium N.V. (AMS Belgium),5the Department, on December 3, 2008, issued its Final Scope Ruling in which it relied upon 19 CFR 351.225(k)(2) to determine that SSPC with a nominal thickness of 4.75mm, but with an actual thickness less than 4.75mm, is included within the scope of theAD and CVD Orders.6

5Formerly known as Ugine & ALZ Belgium N.V. (U&A) and currently known as Aperam Stainless Belgium A.V.

6SeeFinal Scope Ruling at 13-14.

Following a request for a voluntary remand, the CIT remanded the Final Scope Ruling to the Department to reconsider whether SSPC with a nominal thickness of 4.75 mm, but an actual thickness of less than 4.75 mm, is subject to theAD and CVD Orders.7In remanding the case, the Court directed the Department to apply 19 CFR 351.225, in conjunction with the decisions of the CAFC inDuferco Inc.v.United States,296 F.3d 1087 (Fed. Cir. 2002), andTak Fat Trading Co.v.United States,396 F. 3d 1378 (Fed. Cir. 2005).8

On remand, the Department re-examined the language of the scope and, based in part upon interpreting the language in the context of the SSPC industry, determined it to be ambiguous as to whether it covers SSPC with a nominal thickness of 4.75 mm, but an actual thickness of less than 4.75 mm.9Having found the scope language ambiguous, the Department then analyzed the criteria specified by 19 CFR 351.225(k)(1),i.e.,“descriptions of the merchandise contained in the petition, the initial investigation, and the determinations of the Secretary (including prior scope determinations) and the {International TradeCommission},” and found those to be non-dispositive as well.10The Department thus reincorporated its earlier analysis under 19 CFR 351.225(k)(2) to conclude that SSPC with a nominal thickness greater than or equal to 4.75 mm regardless of the actual thickness is included within the scope of theAD and CVD Orders.11

On September 7, 2012, the CAFC reversed the CIT's judgment. The CAFC concluded that substantial evidence did not support the Department's determination that the language of the SSPC orders is ambiguous and held that “the plain meaning of the orders regarding the 4.75 mm thickness is a reference to actual thickness of products subject to the orders.”13

13See ArcelorMittal,694 F.3d at 88-90.

On January 4, 2013, the CIT issued a remand order directing the Department to take action in accordance with the CAFC's decision inArcelorMittaland to find that SSPC with an actual thickness of less than 4.75 mm is outside the scope of theAD and CVD Orders.14Pursuant to that order, the Department construed the scope of theAD and CVD Ordersso that SSPC from Belgium with an actual thickness of less than 4.75 mm is not subject to theAD and CVD Orderson SSPC, regardless of its nominal thickness.15The CIT sustained the Department's remand redetermination on March 26, 2013.16

In its decision inTimken,893 F.2d at 341, as clarified byDiamond Sawblades,the CAFC has held that, pursuant to section 516A(e) of the Tariff Act of 1930, as amended (the Act), the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CAFC's September 7, 2012, judgment inArcelorMittalconstitutes a final decision of that court that is not in harmony with the Department's Final Scope Ruling. This notice is published in fulfillment of the publication requirements ofTimken.

Amended Final Scope Ruling

Because there is now a final court decision with respect to SSPC with an actual thickness of less than 4.75 mm, the Department amends its Final Scope Ruling and now finds that the scope of theAD and CVD Ordersexcludes SSPC with an actual thickness of less than 4.75 mm, regardless of its nominal thickness. Accordingly, the Department will issue revised instructions to U.S. Customs and Border Protection.

This notice is issued and published in accordance with section 516A(c)(1) of the Act.

On February 1, 2013, the Department of Commerce (the Department) published in theFederal Registera notice of “Opportunity to Request Administrative Review” of the antidumping duty order on certain frozen warmwater shrimp from Brazil for the period of review (POR) of February 1, 2012, through January 31, 2013.1The Department received a timely request from the Ad Hoc Shrimp Trade Action Committee (Domestic Producers) in accordance with 19 CFR 351.213(b), for an administrative review of the antidumping duty order on certain frozen warmwater shrimp from Brazil. On March 29, 2013, the Department published a notice of initiation of an administrative review of the antidumping duty order on certain frozen warmwater shrimp from Brazil with respect to two companies.2

The Department stated in its initiation of this review that it intended to rely on U.S. Customs and Border Protection (CBP) data to select respondents.3However, our review of the CBP database, with respect to the companies for which this review was requested, showed no entries of subject merchandise during the POR.4We released the results of our CBP data query to the Domestic Producers, the only interested party to this segment of the proceeding, and invited them to comment on the CBP data. We received no comments on the CBP data.

On April 4, 2013, we sent a “No Shipments Inquiry” to CBP to confirm that there were no shipments or entries of subject merchandise during the POR from the companies subject to review. We received no information from CBP to contradict the results of our data query.

On April 29, 2013, we stated that because information from CBP indicates that there were no entries of subject merchandise during the POR from the companies covered by this review, we intend to rescind this review.5We invited parties to comment on our intent to rescind this administrative review. We did not receive comments from any interested party.

Section 351.213(d)(3) of the Department's regulations stipulates that the Secretary may rescind an administrative review if there were no entries, exports, or sales of the subject merchandise during the POR. As there were no entries, exports, or sales of the subject merchandise during the POR, we are rescinding this review of the antidumping duty order on certain frozen warmwater shrimp from Brazil pursuant to 19 CFR 351.213(d)(3). We intend to issue assessment instructions to CBP 15 days after the date of publication of this notice of rescission of administrative review.

This notice is published in accordance with section 751 of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

The Office of Competition and Economic Analysis (“OCEA”) of the International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (“Certificate”). This notice summarizes the proposed amendment and requests comments relevant to whether the amended Certificate should be issued.

FOR FURTHER INFORMATION CONTACT:

Joseph Flynn, Director, Office of Competition and Economic Analysis, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email atetca@trade.gov.

SUPPLEMENTARY INFORMATION:

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in theFederal Registeridentifying the applicant and summarizing its proposed export conduct.

Request for Public Comments

Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.

An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Export Trading Company Affairs, International Trade Administration, U.S. Department of Commerce, Room 7025X, Washington, DC 20230.

Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 84-24A12.”

The Northwest Fruit Exporters' (“NWF”) original Certificate was issued on June 11, 1984 (49 FR 24581, June 14, 1984), and last amended on January 3, 2013 (78 FR 1837, January 9, 2013). A summary of the current application for an amendment follows.

NMFS has received an application from the U.S. Navy (Navy) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to construction activities as part of a barge mooring project. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to the Navy to take, by Level B Harassment only, four species of marine mammals during the specified activity.

DATES:

Comments and information must be received no later than June 21, 2013.

ADDRESSES:

Comments on the application should be addressed to Michael Payne, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments isITP.Laws@noaa.gov. NMFS is not responsible for email comments sent to addresses other than the one provided here. Comments sent via email, including all attachments, must not exceed a 10-megabyte file size.

Instructions:All comments received are a part of the public record. All Personal Identifying Information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

A copy of the application as well as a list of the references used in this document may be obtained by writing to the address specified above, telephoningthe contact listed below (seeFOR FURTHER INFORMATION CONTACT), or visiting the internet at:http://www.nmfs.noaa.gov/pr/permits/incidental.htm. Supplemental documents provided by the U.S. Navy may be found at the same web address. Documents cited in this notice may also be viewed, by appointment only, at the aforementioned physical address.

FOR FURTHER INFORMATION CONTACT:

Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.

SUPPLEMENTARY INFORMATION:Background

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

Summary of Request

We received an application on February 6, 2013, from the Navy for the taking of marine mammals incidental to pile driving and removal in association with a barge mooring project in the Hood Canal at Naval Base Kitsap in Bangor, WA (NBKB). The Navy submitted a revised version of the application on April 8, 2013, which we deemed adequate and complete. The barge mooring project is expected to require approximately eight weeks and would occur between July 16 and September 30, 2013. Four species of marine mammals are expected to be affected by the specified activities: California sea lion (Zalophus californianus californianus), harbor seal (Phoca vitulina richardii), harbor porpoise (Phocoena phocoena vomerina), and killer whale (transient only;Orcinus orca). These species may occur year-round in the Hood Canal, with the exception of the California sea lion, which is only present from late summer to late spring (August to early June).

NBKB provides berthing and support services to Navy submarines and other fleet assets. Commander Submarine Development Squadron Five (CSDS-5) is a tenant command on NBKB and is the working repository for deep ocean technology and operational, at-sea application of that technology. CSDS-5 currently moors and operates a research barge at the Service Pier on NBKB and is proposing to install mooring for a new larger research barge equipped with upgraded technology necessary for continuing the Navy mission. CSDS-5 currently conducts research equipment operations from an existing 115-ft by 35-ft barge with a 4-ft draft that was constructed in 1940 and cannot accommodate the new research equipment. A new larger barge measuring 260 ft by 85 ft with a 10-ft draft would replace the existing barge. Activities associated with the project include the removal of an existing mooring dolphin, the relocation and addition of floating pier sections, and the installation of up to twenty steel piles to support the barge, electrical transformer platform, and relocated pier sections (see Figures 1-2 and 1-3 in the Navy's application). All steel piles would be driven with a vibratory hammer for their initial embedment depths and may be finished with an impact hammer for proofing, as necessary. Proofing involves striking a driven pile with an impact hammer to verify that it provides the required load-bearing capacity, as indicated by the number of hammer blows per foot of pile advancement. Sound attenuation measures (i.e., bubble curtain) would be used during all impact hammer operations.

For pile driving activities, the Navy used thresholds recommended by NMFS for assessing project impacts, outlined later in this document. The Navy assumed practical spreading loss and used empirically-measured source levels from a similar project conducted at NBKB to estimate potential marine mammal exposures. Predicted exposures are outlined later in this document. The calculations predict that only Level B harassments would occur associated with pile driving or construction activities.

Description of the Specified Activity

NBKB is located on the Hood Canal approximately twenty miles (32 km) west of Seattle, Washington (see Figures 1-1 and 2-1 in the Navy's application). The proposed actions with the potential to cause harassment of marine mammals within the waterways adjacent to NBKB, under the MMPA, are vibratory and impact pile driving and removal of piles via vibratory driver associated with the barge mooring project. All in-water construction activities within the Hood Canal are only permitted during July 16-February 15 in order to protect spawning fish populations; however, the entire barge mooring project is scheduled to be completed by September 30, 2013.

Specific Geographic Region

The Hood Canal is a long, narrow fjord-like basin of the western Puget Sound. Throughout its 67-mile length, the width of the canal varies from one to two miles and exhibits strong depth/elevation gradients and irregular seafloor topography in many areas. Although no official boundaries exist along the waterway, the northeastern section of the canal extending from the mouth of the canal at Admiralty Inlet to the southern tip of Toandos Peninsula is referred to as the northern Hood Canal. NBKB is located within this region (see Figures 2-1 and 2-2 of the Navy's application). Please see Section 2 of the Navy's application for more information about the specific geographic region, including physical and oceanographic characteristics.

Project Description

The project consists of three components: The relocation and addition to the Port Operations pier, the removal of existing infrastructure, and the installation of the CSDS-5 research barge mooring piles. Each element is described below. The barge mooring project is expected to require approximately forty work days and would occur between July 16 and September 30, 2013. Please see Figures 2-2 and 2-3 for details of the proposed project area and site plan.

Relocation of Port Operations

In order to accommodate the new, larger CSDS-5 research barge, some portions of the Port Operations floating pier would be relocated to the south side of the Service Pier trestle. Several floating pier sections/modules would be relocated and seven new modules would be installed to complete the Port Operations infrastructure. Anchoring of the relocated and new floating pier modules would require the installation of three 24-in diameter hollow steel pipe piles. Additionally, four 20-in diameter piles would be installed to support a 12-ft by 16-ft electrical transformer platform.

Removal of Existing Infrastructure

Existing infrastructure must be removed in order to accommodate the new barge, including the existing mooring dolphin and concrete pile cap located north of the proposed relocated floating pier modules. Multiple steel piles would be removed, including six 24-in diameter steel batter piles and two 30-in diameter steel vertical piles. However, only one 24-inch steel pile would be removed with the use of vibratory pile driving equipment. The remaining piles would be removed by cutting them down at the mudline with hydraulic shears or by a diver utilizing a thermal lance, and lifting them out of the water for proper disposal.

Installation of the Barge Mooring Piles

The new research barge will be located at the east side of the Service Pier, and will be moored by five 36-in diameter and up to eight 48-in diameter hollow steel pipe piles. It is more likely that only four 48-in diameter piles would be needed, but this is a conservative estimate in order to ensure some flexibility is maintained for the final design.

In summary, the following is the maximum scenario for project pile driving/removal:

• Four 20-in diameter steel pipe piles approximately 100 ft long will be driven to depth of 55 ft,

• Three 24-in diameter steel pipe piles approximately 60 ft long will be driven to depth of 34 ft,

• Five 36-in diameter steel pipe piles approximately 100 ft long will be driven to depth of 55 ft,

• As many as eight 48-in diameter steel pipe piles approximately 115 ft long may be driven to depth of 70 ft, and

It is anticipated that a maximum of four piles can be driven per day, although this total is unlikely to be reached due to various delays that may be expected during construction work. The total number of days for both extraction and installation are not likely to exceed twenty workdays. Piles will be installed using mainly vibratory pile driving, which involves use of hydraulic-powered weights to vibrate a pile until the surrounding sediment liquefies, enabling the weight of the pile plus the pile driver to push the pile into the ground. For some piles, impact driving may be required to ensure load bearing capacity (proofing) or if substrate conditions do not allow the pile to reach the specified tip elevation with a vibratory driver. An impact hammer uses a rising and falling piston to repeatedly strike a pile and drive it into the ground. When the impact driver is required, it is expected that 500 strikes will be necessary per pile, resulting in approximately 2,000 strikes per day under the maximum scenario. All piles driven with an impact hammer will be surrounded by a bubble curtain or other sound attenuation device over the full water column to minimize in-water noise.

Description of Sound Sources

Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in Hz or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds and attenuate more rapidly in shallower water. Amplitude is the height of the sound pressure wave or the `loudness' of a sound and is typically measured using the decibel (dB) scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by scientific standards). It is a logarithmic unit that accounts for large variations in amplitude; therefore, relatively small changes in dB ratings correspond to large changes in sound pressure. When referring to SPLs (SPLs; the sound force per unit area), sound is referenced in the context of underwater sound pressure to 1 microPascal (μPa). One pascal is the pressure resulting from a force of one newton exerted over an area of one square meter. The source level represents the sound level at a distance of 1 m from the source (referenced to 1 μPa). The received level is the sound level at the listener's position.

Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.

When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones. Underwater sound levels (`ambient sound') are comprised of multiple sources, including physical (e.g., waves, earthquakes, ice, atmospheric sound), biological (e.g., sounds produced by marine mammals, fish, and invertebrates), and anthropogenic sound (e.g., vessels, dredging, aircraft, construction). Even in the absence of anthropogenic sound, the sea is typically a loud environment. A number of sources of sound are likely to occur within Hood Canal, including the following (Richardsonet al.,1995):

• Wind and waves: The complex interactions between wind and water surface, including processes such as breaking waves and wave-induced bubble oscillations and cavitation, are a main source of naturally occurring ambient noise for frequencies between 200 Hz and 50 kHz (Mitson, 1995). Ingeneral, ambient noise levels tend to increase with increasing wind speed and wave height. Surf noise becomes important near shore, with measurements collected at a distance of 8.5 km (5.3 mi) from shore showing an increase of 10 dB in the 100 to 700 Hz band during heavy surf conditions.

• Precipitation noise: Noise from rain and hail impacting the water surface can become an important component of total noise at frequencies above 500 Hz, and possibly down to 100 Hz during quiet times.

• Biological noise: Marine mammals can contribute significantly to ambient noise levels, as can some fish and shrimp. The frequency band for biological contributions is from approximately 12 Hz to over 100 kHz.

• Anthropogenic noise: Sources of ambient noise related to human activity include transportation (surface vessels and aircraft), dredging and construction, oil and gas drilling and production, seismic surveys, sonar, explosions, and ocean acoustic studies (Richardsonet al.,1995). Shipping noise typically dominates the total ambient noise for frequencies between 20 and 300 Hz. In general, the frequencies of anthropogenic sounds are below 1 kHz and, if higher frequency sound levels are created, they will attenuate (decrease) rapidly (Richardsonet al.,1995). Known sound levels and frequency ranges associated with anthropogenic sources similar to those that would be used for this project are summarized in Table 1. Details of each of the sources are described in the following text.

In-water construction activities associated with the project would include impact pile driving, vibratory pile driving and removal, and possibly pneumatic chipping. The sounds produced by these activities fall into one of two sound types: pulsed and non-pulsed (defined in next paragraph). The distinction between these two general sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (e.g., Ward, 1997 in Southallet al.,2007). Please see Southallet al.,(2007) for an in-depth discussion of these concepts.

Pulsed sounds (e.g., explosions, gunshots, sonic booms, and impact pile driving) are brief, broadband, atonal transients (ANSI, 1986; Harris, 1998) and occur either as isolated events or repeated in some succession. Pulsed sounds are all characterized by a relatively rapid rise from ambient pressure to a maximal pressure value followed by a decay period that may include a period of diminishing, oscillating maximal and minimal pressures. Pulsed sounds generally have an increased capacity to induce physical injury as compared with sounds that lack these features.

Non-pulse (intermittent or continuous sounds) can be tonal, broadband, or both. Some of these non-pulse sounds can be transient signals of short duration but without the essential properties of pulses (e.g., rapid rise time). Examples of non-pulse sounds include those produced by vessels, aircraft, machinery operations such as drilling or dredging, vibratory pile driving, and active sonar systems. The duration of such sounds, as received at a distance, can be greatly extended in a highly reverberant environment.

Impact hammers operate by repeatedly dropping a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper, 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers produce significantly less sound than impact hammers. Peak SPLs may be 180 dB or greater, but are generally 10 to 20 dB lower than SPLs generated during impact pile driving of the same-sized pile (Oestmanet al.,2009). Rise time is slower, reducing the probability and severity of injury, and sound energy is distributed over a greater amount of time (Nedwell and Edwards, 2002; Carlsonet al.,2005).

Ambient Sound

The underwater acoustic environment consists of ambient sound, defined as environmental background sound levels lacking a single source or point (Richardsonet al.,1995). The ambient underwater sound level of a region is defined by the total acoustical energy being generated by known and unknown sources, including sounds from both natural and anthropogenic sources. The sum of the various natural and anthropogenic sound sources at any given location and time depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, the ambient sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardsonet al.,1995).

Sound levels can be greatly reduced during impact pile driving using sound attenuation devices. There are severaltypes of sound attenuation devices including bubble curtains, cofferdams, and isolation casings (also called temporary noise attenuation piles [TNAP]), and cushion blocks. The Navy proposes to use bubble curtains, which create a column of air bubbles rising around a pile from the substrate to the water surface. The air bubbles absorb and scatter sound waves emanating from the pile, thereby reducing the sound energy. Bubble curtains may be confined or unconfined. An unconfined bubble curtain may consist of a ring seated on the substrate and emitting air bubbles from the bottom. An unconfined bubble curtain may also consist of a stacked system, that is, a series of multiple rings placed at the bottom and at various elevations around the pile. Stacked systems may be more effective than non-stacked systems in areas with high current and deep water (Oestmanet al.,2009).

A confined bubble curtain contains the air bubbles within a flexible or rigid sleeve made from plastic, cloth, or pipe. Confined bubble curtains generally offer higher attenuation levels than unconfined curtains because they may physically block sound waves and they prevent air bubbles from migrating away from the pile. For this reason, the confined bubble curtain is commonly used in areas with high current velocity (Oestmanet al.,2009).

Both environmental conditions and the characteristics of the sound attenuation device may influence the effectiveness of the device. According to Oestmanet al.(2009):

• In general, confined bubble curtains attain better sound attenuation levels in areas of high current than unconfined bubble curtains. If an unconfined device is used, high current velocity may sweep bubbles away from the pile, resulting in reduced levels of sound attenuation.

• Softer substrates may allow for a better seal for the device, preventing leakage of air bubbles and escape of sound waves. This increases the effectiveness of the device. Softer substrates also provide additional attenuation of sound traveling through the substrate.

• Air bubbles must be close to the pile; otherwise, sound may propagate into the water, reducing the effectiveness of the device.

• Harder substrates may transmit ground-borne sound and propagate it into the water column.

The literature presents a wide array of observed attenuation results for bubble curtains (e.g., Oestmanet al.,2009, Coleman, 2011, California Department of Transportation, 2012). The variability in attenuation levels is due to variation in design, as well as differences in site conditions and difficulty in properly installing and operating in-water attenuation devices. As a general rule, reductions of greater than 10 dB cannot be reliably predicted. The TPP reported a range of measured values for realized attenuation mostly within 6 to 12 dB (Illingworth & Rodkin, Inc., 2012). For 36-inch piles the average peak and rms reduction with use of the bubble curtain was 8 dB, where the averages of all bubble-on and bubble-off data were compared. For 48-inch piles, the average SPL reduction with use of a bubble curtain was 6 dB for average peak values and 5 dB for rms values (see Table 3). To avoid loss of attenuation from design and implementation errors, the Navy has required specific bubble curtain design specifications, including testing requirements for air pressure and flow prior to initial impact hammer use, and a requirement for placement on the substrate. We considered previous assumptions regarding effectiveness of the bubble curtain (approximately 10 dB realized attenuation, TPP measurements (approximately 7 dB overall), and other monitored projects (typically at least 8 dB realized attenuation), and determined that 8 dB is a realistic and achievable estimate of average SPL (rms) reduction.

Sound Thresholds

NMFS uses generic sound exposure thresholds to determine when an activity that produces sound might result in impacts to a marine mammal such that a take by harassment might occur. To date, no studies have been conducted that examine impacts to marine mammals from pile driving sounds from which empirical sound thresholds have been established. Current NMFS practice (in relation to the MMPA) regarding exposure of marine mammals to sound is that cetaceans and pinnipeds exposed to impulsive sounds of 180 and 190 dB rms or above, respectively, are considered to have been taken by Level A (i.e., injurious) harassment. Behavioral harassment (Level B) is considered to have occurred when marine mammals are exposed to sounds at or above 160 dB rms for impulse sounds (e.g., impact pile driving) and 120 dB rms for continuous sound (e.g., vibratory pile driving), but below injurious thresholds. For airborne sound, pinniped disturbance from haul-outs has been documented at 100 dB (unweighted) for pinnipeds in general, and at 90 dB (unweighted) for harbor seals. NMFS uses these levels as guidelines to estimate when harassment may occur.

Distance to Sound Thresholds

Underwater Sound Propagation Formula—Pile driving would generate underwater noise that potentially could result in disturbance to marine mammals in the project area. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

TL = B * log10(R1/R2)where:R1= the distance of the modeled SPL from the driven pile, andR2= the distance from the driven pile of the initial measurement.This formula neglects loss due to scattering and absorption, which is assumed to be zero here. The degree to which underwater sound propagates away from a sound source is dependent on a variety of factors, most notably by the water bathymetry and presence or absence of reflective or absorptive conditions including in-water structures and sediments. Spherical spreading occurs in a perfectly unobstructed (free-field) environment not limited by depth or water surface, resulting in a 6 dB reduction in sound level for each doubling of distance from the source (20*log[range]). Cylindrical spreading occurs in an environment in which sound propagation is bounded by the water surface and sea bottom, resulting in a reduction of 3 dB in sound level for each doubling of distance from the source (10*log[range]). A practical spreading value of 15 is often used under conditions, such as Hood Canal, where water increases with depth as the receiver moves away from the shoreline, resulting in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions. Practical spreading loss (4.5 dB reduction in sound level for each doubling of distance) is assumed here.

Underwater Sound—The intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. The Navy previously conducted measurements for driving of steel pilesat NBKB as part of the TPP (Illingworth & Rodkin, Inc., 2012), and we have determined that use of those values is appropriate to determine reasonable SPLs and their associated affects on marine mammals that are likely to result from pile driving at NBKB. During the TPP, SPLs from driving of 24-, 36-, and 48-in piles by impact and vibratory hammers were measured. Because 20-in piles were not measured during the TPP, we use sound pressure levels from the 24-in piles as a conservative estimate. Sound levels associated with vibratory pile removal are assumed to be the same as those during vibratory installation (Reyff, 2007)—which is likely a conservative assumption—and have been taken into consideration in the modeling analysis. Results of the TPP are shown in Table 2.

Because it is unknown what size pile may be driven on any given day, the Navy uses the most conservative values (i.e., 196 dB for impact driving and 172 dB for vibratory driving), and practical spreading loss, to estimate distances to relevant thresholds and associated areas of ensonification (presented in Table 3). Predicted distances to thresholds for different sources are shown in Figures 6-1 and 6-2 of the Navy's application. The predicted area exceeding the threshold assumes a field free of obstruction, which is unrealistic due to land masses or bends in the canal. The actual distance to the behavioral disturbance thresholds for pile driving may be shorter than the calculated distance due to the irregular contour of the waterfront, the narrowness of the canal, and the maximum fetch (furthest distance sound waves travel without obstruction [i.e., line of site]) at the project area.

Airborne Sound—Pile driving can generate airborne sound that could potentially result in disturbance to marine mammals (specifically, pinnipeds) which are hauled out or at the water's surface. As a result, the Navy analyzed the potential for pinnipeds hauled out or swimming at the surface near NBKB to be exposed to airborne SPLs that could result in Level B behavioral harassment. Although there is no official airborne sound threshold, NMFS assumes for purposes of the MMPA that behavioral disturbance can occur upon exposure to sounds above 100 dB re 20 μPa rms (unweighted) for all pinnipeds, except harbor seals. For harbor seals, the threshold is 90 dB re 20 μPa rms (unweighted).

As was discussed for underwater sound from pile driving, the intensity of pile driving sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. As before, measured values from the TPP were used to determine reasonable airborne SPLs and their associated effects on marine mammals that are likely to result from pile driving at NBKB. During the TPP, vibratory driving was measured at 102 dB re 20 μPa rms at 15 m and impact driving at 109 dB re 20 μPa rms at 15 m.

Based on these values and the assumption of spherical spreading loss, distances to relevant thresholds and associated areas of ensonification are presented in Table 4; these areas are depicted in Tables 6-3 and 6-4 of the Navy's application. There are no haul-out locations within these zones, which are encompassed by the zones estimated for underwater sound. Protective measures would be in place out to the distances calculated for the underwater thresholds, and the distances for the airborne thresholds would be covered fully by mitigation and monitoring measures in place for underwater sound thresholds. We recognize that pinnipeds in water that are within the area of ensonification for airborne sound could be incidentally taken by either underwater or airborne sound or both. We consider these incidences of harassment to be accounted for in the take estimates for underwater sound.

There are seven marine mammal species, four cetaceans and three pinnipeds, which may inhabit or transit through the waters nearby NBKB in the Hood Canal. These include the transient killer whale, harbor porpoise, Dall's porpoise (Phocoenoides dalli dalli), Steller sea lion (eastern stock only;Eumetopias jubatus monteriensis), California sea lion, harbor seal, and humpback whale (Megaptera novaeangliae). The Steller sea lion and humpback whale are the only marine mammals that may occur within the Hood Canal that are listed under the Endangered Species Act (ESA); the humpback whale is listed as endangered and the eastern distinct population segment (DPS) of Steller sea lion is listed as threatened. The Steller sea lion is typically present in low numbers in the Hood Canal only from approximately October through mid-April. The humpback whale is not typically present in Hood Canal, with no confirmed sightings found in the literature or the Orca Network database prior to January and February 2012, when one individual was observed repeatedly over a period of several weeks. No sightings have been recorded since that time and we consider the humpback whale to be a rare visitor to Hood Canal at most. While the southern resident killer whale is resident to the inland waters of Washington and British Columbia, it has not been observed in the Hood Canal in over 15 years. Therefore, these three stocks were excluded from further analysis.

This section summarizes the population status and abundance of these species. We have reviewed the Navy's detailed species descriptions, including life history information, for accuracy and completeness and refer the reader to Sections 3 and 4 of the Navy's application instead of reprinting the information here. Table 5 lists the marine mammal species with expected potential for occurrence in the vicinity of NBKB during the project timeframe. The following information is summarized largely from NMFS Stock Assessment Reports.

Table 5—Marine Mammals Present in the Hood Canal in the Vicinity of NBKBSpeciesStock abundance1

Harbor seals inhabit coastal and estuarine waters and shoreline areas of the northern hemisphere from temperate to polar regions. The eastern North Pacific subspecies is found from Baja California north to the Aleutian Islands and into the Bering Sea. Multiple lines of evidence support the existence of geographic structure among harbor seal populations from California to Alaska (Carrettaet al.,2011). However, because stock boundaries are difficult to meaningfully draw from a biological perspective, three separate harbor seal stocks are recognized for management purposes along the west coast of the continental U.S.: (1) Inland waters of Washington (including Hood Canal, Puget Sound, and the Strait of Juan de Fuca out to Cape Flattery), (2) outer coast of Oregon and Washington, and (3) California (Carrettaet al.,2011). Multiple stocks are recognized in Alaska. Samples from Washington, Oregon, and California demonstrate a high level of genetic diversity and indicate that the harbor seals of Washington inland waters possess unique haplotypes not found in seals from the coasts of Washington, Oregon, and California (Lamontet al.,1996). Only the Washington inland waters stock may be found in the project area.

Washington inland waters harbor seals are not protected under the ESA or listed as depleted under the MMPA. Because there is no current abundance estimate for this stock, there is no current estimate of potential biological removal (PBR). However, because annual human-caused mortality (13) is significantly less than the previously calculated PBR (771) the stock is not considered strategic under the MMPA. The stock is considered to be within its optimum sustainable population (OSP) level.

The best abundance estimate of the Washington inland waters stock of harbor seals is 14,612 (CV = 0.15) and the minimum population size of this stock is 12,884 individuals (Carrettaet al.,2011). Aerial surveys of harbor seals in Washington were conducted during the pupping season in 1999, during which time the total numbers of hauled-out seals (including pups) were counted (Jeffrieset al.,2003). Radio-tagging studies conducted at six locations collected information on harbor seal haul-out patterns in 1991-92, resulting in a correction factor of 1.53 (CV = 0.065) to account for animals in the water which are missed during the aerial surveys (Huberet al.,2001), which, coupled with the aerial survey counts, provides the abundance estimate. Because the estimate is greater than eight years old, NMFS does not consider it current. However, it does represent the best available information regarding stock abundance. Harbor seal counts in Washington State increased at an annual rate of ten percent from 1991-96 (Jeffrieset al.,1997). However, a logistic model fit to abundance data from 1978-99 resulted in an estimated maximum net productivity rate of 12.6 percent (95% CI = 9.4-18.7%) and the population is thought to be stable (Jeffrieset al.,2003).

Historical levels of harbor seal abundance in Washington are unknown. The population was apparently greatly reduced during the 1940s and 1950s due to a state-financed bounty program andremained low during the 1970s before rebounding to current levels (Carrettaet al.,2011). Data from 2004-08 indicate that a minimum of 3.8 harbor seals are killed annually in Washington inland waters commercial fisheries (Carrettaet al.,2011). Animals captured east of Cape Flattery are assumed to belong to this stock. The estimate is considered a minimum because there are likely additional animals killed in unobserved fisheries and because not all animals stranding as a result of fisheries interactions are likely to be recorded. Another 9.2 harbor seals per year are estimated to be killed as a result of various non-fisheries human interactions (Carrettaet al.,2011). Tribal subsistence takes of this stock may occur, but no data on recent takes are available.

Harbor seals are the most abundant marine mammal in Hood Canal, where they can occur anywhere year-round, and are the only pinniped that breeds in inland Washington waters and the only species of marine mammal that is considered resident in the Hood Canal (Jeffrieset al.,2003). They are year-round, non-migratory residents, pup (i.e., give birth) in Hood Canal, and the population is considered closed, meaning that they do not have much movement outside of Hood Canal (London, 2006). Surveys in the Hood Canal from the mid-1970s to 2000 show a fairly stable population between 600-1,200 seals, and the abundance of harbor seals in Hood Canal has likely stabilized at its carrying capacity of approximately 1,000 seals (Jeffrieset al.,2003).

Harbor seals were consistently sighted during Navy surveys and were found in all marine habitats including nearshore waters and deeper water, and have been observed hauled out on manmade objects such as buoys. Harbor seals were commonly observed in the water during monitoring conducted for other projects at NBKB in 2011. During most of the year, all age and sex classes (except newborn pups) could occur in the project area throughout the period of construction activity. Since there are no known pupping sites in the vicinity of the project area, harbor seal neonates would not generally be expected to be present during pile driving. Otherwise, during most of the year, all age and sex classes could occur in the project area throughout the period of construction activity. Harbor seal numbers increase from January through April and then decrease from May through August as the harbor seals move to adjacent bays on the outer coast of Washington for the pupping season. From April through mid-July, female harbor seals haul out on the outer coast of Washington at pupping sites to give birth. The main haul-out locations for harbor seals in Hood Canal are located on river delta and tidal exposed areas, with the closest haul-out to the project area being approximately ten miles (16 km) southwest of NBKB at Dosewallips River mouth, outside the potential area of effect for this project (London, 2006; see Figure 4-1 of the Navy's application).

California Sea Lion

California sea lions range from the Gulf of California north to the Gulf of Alaska, with breeding areas located in the Gulf of California, western Baja California, and southern California. Five genetically distinct geographic populations have been identified: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California and (5) Northern Gulf of California (Schrammet al.,2009). Rookeries for the Pacific Temperate population are found within U.S. waters and just south of the U.S.-Mexico border, and animals belonging to this population may be found from the Gulf of Alaska to Mexican waters off Baja California. For management purposes, a stock of California sea lions comprising those animals at rookeries within the U.S. is defined (i.e., the U.S. stock of California sea lions) (Carrettaet al.,2011). Pup production at the Coronado Islands rookery in Mexican waters is considered an insignificant contribution to the overall size of the Pacific Temperate population (Lowry and Maravilla-Chavez, 2005).

California sea lions are not protected under the ESA or listed as depleted under the MMPA. Total annual human-caused mortality (at least 431) is substantially less than the potential biological removal (PBR, estimated at 9,200 per year); therefore, California sea lions are not considered a strategic stock under the MMPA. There are indications that the California sea lion may have reached or is approaching carrying capacity, although more data are needed to confirm that leveling in growth persists (Carrettaet al.,2011).

The best abundance estimate of the U.S. stock of California sea lions is 296,750 and the minimum population size of this stock is 153,337 individuals (Carrettaet al.,2011). The entire population cannot be counted because all age and sex classes are never ashore at the same time; therefore, the best abundance estimate is determined from the number of births and the proportion of pups in the population, with censuses conducted in July after all pups have been born. Specifically, the pup count for rookeries in southern California from 2008 was adjusted for pre-census mortality and then multiplied by the inverse of the fraction of newborn pups in the population (Carrettaet al.,2011). The minimum population size was determined from counts of all age and sex classes that were ashore at all the major rookeries and haul-out sites in southern and central California during the 2007 breeding season, including all California sea lions counted during the July 2007 census at the Channel Islands in southern California and at haul-out sites located between Point Conception and Point Reyes, California (Carrettaet al.,2011). An additional unknown number of California sea lions are at sea or hauled out at locations that were not censused and are not accounted for in the minimum population size.

Trends in pup counts from 1975 through 2008 have been assessed for four rookeries in southern California and for haul-outs in central and northern California. During this time period counts of pups increased at an annual rate of 5.4 percent, excluding six El Niño years when pup production declined dramatically before quickly rebounding (Carrettaet al.,2011). The maximum population growth rate was 9.2 percent when pup counts from the El Niño years were removed. However, the apparent growth rate from the population trajectory underestimates the intrinsic growth rate because it does not consider human-caused mortality occurring during the time series; the default maximum net productivity rate for pinnipeds (12 percent per year) is considered appropriate for California sea lions (Carrettaet al.,2011).

Historic exploitation of California sea lions include harvest for food by Native Americans in pre-historic times and for oil and hides in the mid-1800s, as well as exploitation for a variety of reasons more recently (Carrettaet al.,2011). There are few historical records to document the effects of such exploitation on sea lion abundance (Lowryet al.,1992). Data from 2003-09 indicate that a minimum of 337 (CV = 0.56) California sea lions are killed annually in commercial fisheries. In addition, a summary of stranding database records for 2005-09 shows an annual average of 65 such events, which is likely a gross underestimate because most carcasses are not recovered. California sea lions may also be removed because of predation on endangered salmonids (17 per year, 2008-10) or incidentally captured during scientific research (3 per year, 2005-09) (Carrettaet al.,2011). Sea lion mortality has also been linked to thealgal-produced neurotoxin domoic acid (Scholinet al.,2000). There is currently an Unusual Mortality Event (UME) declaration in effect for California sea lions. Future mortality may be expected to occur, due to the sporadic occurrence of such harmful algal blooms. Beginning in January 2013, elevated strandings of California sea lion pups have been observed in Southern California, with live sea lion strandings nearly three times higher than the historical average. The causes of this UME are under investigation (http://www.nmfs.noaa.gov/pr/health/mmume/californiasealions2013.htm;accessed April 10, 2013).

An estimated 3,000 to 5,000 California sea lions migrate northward along the coast to central and northern California, Oregon, Washington, and Vancouver Island during the non-breeding season from September to May (Jeffrieset al.,2000) and return south the following spring (Mate, 1975; Bonnellet al.,1983). Peak numbers of up to 1,000 California sea lions occur in Puget Sound (including Hood Canal) during this time period (Jeffrieset al.,2000).

California sea lions are present in Hood Canal during much of the year with the exception of mid-June through August, and occur regularly at NBKB, as observed during Navy waterfront surveys conducted from April 2008 through June 2010 (Navy, 2010). They are known to utilize a diversity of man-made structures for hauling out (Riedman, 1990) and, although there are no regular California sea lion haul-outs known within the Hood Canal (Jeffrieset al.,2000), they are frequently observed hauled out at several opportune areas at NBKB (e.g., submarines, floating security fence, barges). As many as 81 California sea lions have been observed hauled out on a single day at NBKB (Agness and Tannenbaum, 2009a; Tannenbaumet al.,2009a; Navy, 2011). All documented instances of California sea lions hauling out at NBKB have been on submarines docked at Delta Pier, approximately 0.85 mi north of Service Pier, and on pontoons of the security fence. California sea lions have also been observed swimming near the Explosives Handling Wharf on several occasions, approximately 1.85 mi north of Service Pier (Tannenbaumet al. 2009; Navy 2010), and likely forage in both nearshore and inland marine deeper water habitats in the vicinity.

Killer Whale

Killer whales are one of the most cosmopolitan marine mammals, found in all oceans with no apparent restrictions on temperature or depth, although they do occur at higher densities in colder, more productive waters at high latitudes and are more common in nearshore waters (Leatherwood and Dahlheim, 1978; Forney and Wade, 2006; Allen and Angliss, 2011). Killer whales are found throughout the North Pacific, including the entire Alaska coast, in British Columbia and Washington inland waterways, and along the outer coasts of Washington, Oregon, and California. On the basis of differences in morphology, ecology, genetics, and behavior, populations of killer whales have largely been classified as “resident”, “transient”, or “offshore” (e.g., Dahlheimet al.,2008). Several studies have also provided evidence that these ecotypes are genetically distinct, and that further genetic differentiation is present between subpopulations of the resident and transient ecotypes (e.g., Barrett-Lennard, 2000). The taxonomy of killer whales is unresolved, with expert opinion generally following one of two lines: Killer whales are either (1) a single highly variable species, with locally differentiated ecotypes representing recently evolved and relatively ephemeral forms not deserving species status, or (2) multiple species, supported by the congruence of several lines of evidence for the distinctness of sympatrically occurring forms (Krahnet al.,2004). Resident and transient whales are currently considered to be unnamed subspecies (Committee on Taxonomy, 2011).

The resident and transient populations have been divided further into different subpopulations on the basis of genetic analyses, distribution, and other factors. Recognized stocks in the North Pacific include Alaska Residents, Northern Residents, Southern Residents, Gulf of Alaska, Aleutian Islands, and Bering Sea Transients, and West Coast Transients, along with a single offshore stock. West Coast Transient killer whales, which occur from California through southeastern Alaska, are the only type expected to potentially occur in the project area.

West Coast Transient killer whales are not protected under the ESA or listed as depleted under the MMPA. The estimated annual level of human-caused mortality (0) does not exceed the calculated PBR (3.5); therefore, West Coast Transient killer whales are not considered a strategic stock under the MMPA. It is thought that the stock grew rapidly from the mid-1970s to mid-1990s as a result of a combination of high birth rate, survival, as well as greater immigration of animals into the nearshore study area (DFO, 2009). The rapid growth of the population during this period coincided with a dramatic increase in the abundance of the whales' primary prey, harbor seals, in nearshore waters. Population growth began slowing in the mid-1990s and has continued to slow in recent years (DFO, 2009). Population trends and status of this stock relative to its OSP level are currently unknown, as is the actual maximum productivity rate. Analyses in DFO (2009) estimated a rate of increase of about six percent per year from 1975 to 2006, but this included recruitment of non-calf whales into the population. The default maximum net growth rate for cetaceans (4 percent) is considered appropriate pending additional information (Carrettaet al.,2011).

The West Coast transient stock is a trans-boundary stock, with minimum counts for the population of transient killer whales coming from various photographic datasets. Combining these counts of cataloged transient whales gives an abundance estimate of 354 individuals for the West Coast transient stock (Allen and Angliss, 2011). Although this direct count of individually identifiable animals does not necessarily represent the number of live animals, it is considered a conservative minimum estimate (Allen and Angliss, 2011). However, the number in Washington waters at any one time is probably fewer than twenty individuals (Wiles, 2004). The West Coast transient killer whale stock is not designated as depleted under the MMPA or listed under the ESA. The estimated annual level of human-caused mortality and serious injury does not exceed the PBR. Therefore, the West Coast Transient stock of killer whales is not classified as a strategic stock.

The estimated minimum mortality rate incidental to U.S. commercial fisheries is zero animals per year (Allen and Angliss, 2011). However, this could represent an underestimate as regards total fisheries-related mortality due to a lack of data concerning marine mammal interactions in Canadian commercial fisheries known to have potential for interaction with killer whales. Any such interactions are thought to be few in number (Allen and Angliss, 2011). Other mortality, as a result of shootings or ship strikes, has been of concern in the past. However, no ship strikes have been reported for this stock, and shooting of transients is thought to be minimal because their diet is based on marine mammals rather than fish. There are no reports of a subsistence harvest of killer whales in Alaska or Canada.

Transient occurrence in inland waters appears to peak during August and September which is the peak time for harbor seal pupping, weaning, and post-weaning (Baird and Dill, 1995). In 2003 and 2005, small groups of transient killer whales (eleven and six individuals, respectively) were present in Hood Canal for significant periods of time (59 and 172 days, respectively) between the months of January and July. While present, the whales preyed on harbor seals in the subtidal zone of the nearshore marine and inland marine deeper water habitats (London, 2006).

Dall's Porpoise

Dall's porpoises are endemic to temperate waters of the North Pacific, typically in deeper waters between 30-62°N, and are found from northern Baja California to the northern Bering Sea. Stock structure for Dall's porpoises is not well known; because there are no cooperative management agreements with Mexico or Canada for fisheries which may take this species, Dall's porpoises are divided for management purposes into two discrete, noncontiguous areas: (1) Waters off California, Oregon, and Washington, and (2) Alaskan waters (Carrettaet al.,2011). Only individuals from the CA/OR/WA stock may occur within the project area.

Dall's porpoises are not protected under the ESA or listed as depleted under the MMPA. The minimum estimate of annual human-caused mortality (0.4) is substantially less than the calculated PBR (257); therefore, Dall's porpoises are not considered a strategic stock under the MMPA. The status of Dall's porpoises in California, Oregon and Washington relative to OSP is not known (Carrettaet al.,2011).

Dall's porpoise distribution on the U.S. west coast is highly variable between years and appears to be affected by oceanographic conditions (Forney and Barlow, 1998); animals may spend more or less time outside of U.S. waters as oceanographic conditions change. Therefore, a multi-year average of 2005 and 2008 summer/autumn vessel-based line transect surveys of California, Oregon, and Washington waters was used to estimate a best abundance of 42,000 (CV = 0.33) animals (Forney, 2007; Barlow, 2010). The minimum population is considered to be 32,106 animals. Dall's porpoises also occur in the inland waters of Washington, but the most recent estimate was obtained in 1996 (900 animals; CV = 0.40; Calambokidiset al.,1997) and is not included in the overall estimate of abundance for this stock. Because distribution and abundance of this stock is so variable, population trends are not available (Carrettaet al.,2011). No information is available regarding productivity rates, and the default maximum net growth rate for cetaceans (4 percent) is considered appropriate (Carrettaet al.,2011).

Data from 2002-08, from all fisheries for which mortality data are available, indicate that a minimum of 0.4 animals are killed per year (Carrettaet al.,2011). Species-specific information is not available for Mexican fisheries, which could be an additional source of mortality for animals beyond the stock boundaries delineated for management purposes. No other sources of human-caused mortality are known.

In Washington, Dall's porpoises are most abundant in offshore waters where they are year-round residents, although interannual distribution is highly variable (Greenet al.,1992). Dall's porpoises are observed throughout the year in the Puget Sound north of Seattle, are seen occasionally in southern Puget Sound, and may also occasionally occur in Hood Canal. However, only a single Dall's porpoise has been observed at NBKB, in deeper water during a 2008 summer survey (Tannenbaumet al.,2009a).

Harbor Porpoise

Harbor porpoises are found primarily in inshore and relatively shallow coastal waters (< 100 m) from Point Barrow to Point Conception. Various genetic analyses and investigation of pollutant loads indicate a low mixing rate for harbor porpoise along the west coast of North America and likely fine-scale geographic structure along an almost continuous distribution from California to Alaska (e.g., Calambokidis and Barlow, 1991; Osmeket al.,1994; Chiverset al.,2002, 2007). However, stock boundaries are difficult to draw because any rigid line is generally arbitrary from a biological perspective. On the basis of genetic data and density discontinuities identified from aerial surveys, eight stocks have been identified in the eastern North Pacific, including northern Oregon/Washington coastal and inland Washington stocks (Carrettaet al.,2011). The Washington inland waters stock includes individuals found east of Cape Flattery and is the only stock that may occur in the project area.

Harbor porpoises of Washington inland waters are not protected under the ESA or listed as depleted under the MMPA. Because there is no current abundance estimate for this stock, there is no current estimate of PBR. However, because annual human-caused mortality (2.6) is less than the previously calculated PBR (63) the stock is not considered strategic under the MMPA. The status of harbor porpoises in Washington inland waters relative to OSP is not known (Carrettaet al.,2011).

The best estimate of abundance for this stock is derived from aerial surveys of the inland waters of Washington and southern British Columbia conducted during August of 2002 and 2003. When corrected for availability and perception bias, the average of the 2002-03 estimates of abundance for U.S. waters resulted in an estimated abundance for the Washington Inland Waters stock of harbor porpoise of 10,682 (CV = 0.38) animals (Laakeet al.,1997; Carrettaetal.,2011), with a minimum population estimate of 7,841 animals. Because the estimate is greater than eight years old, NMFS does not consider it current. However, it does represent the best available information regarding stock abundance.

Although long-term harbor porpoise sightings in southern Puget Sound declined from the 1940s through the 1990s, sightings and strandings have increased in Puget Sound and northern Hood Canal in recent years and harbor porpoise are now considered to regularly occur year-round in these waters (Carrettaet al.,2011). Reasons for the apparent decline, as well as the apparent rebound, are unknown. Recent observations may represent a return to historical conditions, when harbor porpoises were considered one of the most common cetaceans in Puget Sound (Scheffer and Slipp, 1948). No information regarding productivity is available for this stock and NMFS considers the default maximum net productivity rate for cetaceans (4 percent) to be appropriate.

Data from 2005-09 indicate that a minimum of 2.2 Washington inland waters harbor seals are killed annually in U.S. commercial fisheries (Carrettaet al.,2011). Animals captured in waters east of Cape Flattery are assumed to belong to this stock. This estimate is considered a minimum because the Washington Puget Sound Region salmon set/drift gillnet fishery has not been observed since 1994, and because of a lack of knowledge about the extent to which harbor porpoise from U.S. waters frequent the waters of British Columbia and are, therefore, subject to fishery-related mortality. However, harbor porpoise takes in the salmon drift gillnet fishery are unlikely to have increased since the fishery was last observed, when few interactions were recorded, due to reductions in the number of participating vessels and available fishing time. Fishing effort and catch have declined throughout all salmon fisheries in the region due to management efforts to recover ESA-listed salmonids (Carrettaet al.,2011).In addition, an estimated 0.4 animals per year are killed by non-fishery human causes (e.g., ship strike, entanglement). In 2006, a UME was declared for harbor porpoises throughout Oregon and Washington, and a total of 114 strandings were reported in 2006-07. The cause of the UME has not been determined and several factors, including contaminants, genetics, and environmental conditions, are still being investigated (Carrettaet al.,2011).

Prior to recent construction projects conducted by the Navy at NBKB, harbor porpoises were considered to have only occasional occurrence in the project area. A single harbor porpoise had been sighted in deeper water at NBKB during 2010 field observations (Tannenbaumet al.,2011). However, while implementing monitoring plans for work conducted from July-October, 2011, the Navy recorded multiple sightings of harbor porpoise in the deeper waters of the project area (HDR, Inc., 2012). Following these sightings, the Navy conducted dedicated line transect surveys, recording multiple additional sightings of harbor porpoise, and have revised local density estimates accordingly.

Potential Effects of the Specified Activity on Marine Mammals

We have determined that pile driving and removal (depending on technique used), as outlined in the project description, has the potential to result in behavioral harassment of marine mammals present in the project area. Pinnipeds spend much of their time in the water with heads held above the surface and therefore are not subject to underwater noise to the same degree as cetaceans (although they are correspondingly more susceptible to exposure to airborne sound). For purposes of this assessment, however, pinnipeds are conservatively assumed to be available to be exposed to underwater sound 100 percent of the time that they are in the water.

Marine Mammal Hearing

The primary effect on marine mammals anticipated from the specified activities would result from exposure of animals to underwater sound. Exposure to sound can affect marine mammal hearing. When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data, Southallet al.(2007) designate functional hearing groups for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

• Low frequency cetaceans (thirteen species of mysticetes): Functional hearing is estimated to occur between approximately 7 Hz and 22 kHz;

• Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and nineteen species of beaked and bottlenose whales): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

• High frequency cetaceans (six species of true porpoises, four species of river dolphins, two members of the genusKogia,and four dolphin species of the genusCephalorhynchus): Functional hearing is estimated to occur between approximately 200 Hz and 180 kHz; and

• Pinnipeds in water: Functional hearing is estimated to occur between approximately 75 Hz and 75 kHz, with the greatest sensitivity between approximately 700 Hz and 20 kHz.

Two pinniped and three cetacean species could potentially occur in the proposed project area during the project timeframe. Of the cetacean species that may occur in the project area, the killer whale is classified as a mid-frequency cetacean, and the two porpoises are classified as high-frequency cetaceans (Southallet al.,2007).

Underwater Sound Effects

Potential Effects of Pile Driving Sound—The effects of sounds from pile driving might result in one or more of the following: Temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, and masking (Richardsonet al.,1995; Gordonet al.,2004; Nowaceket al.,2007; Southallet al.,2007). The effects of pile driving on marine mammals are dependent on several factors, including the size, type, and depth of the animal; the depth, intensity, and duration of the pile driving sound; the depth of the water column; the substrate of the habitat; the standoff distance between the pile and the animal; and the sound propagation properties of the environment. Impacts to marine mammals from pile driving activities are expected to result primarily from acoustic pathways. As such, the degree of effect is intrinsically related to the received level and duration of the sound exposure, which are in turn influenced by the distance between the animal and the source. The further away from the source, the less intense the exposure should be. The substrate and depth of the habitat affect the sound propagation properties of the environment. Shallow environments are typically more structurally complex, which leads to rapid sound attenuation. In addition, substrates that are soft (e.g., sand) would absorb or attenuate the sound more readily than hard substrates (e.g., rock) which may reflect the acoustic wave. Soft porous substrates would also likely require less time to drive the pile, and possibly less forceful equipment, which would ultimately decrease the intensity of the acoustic source.

In the absence of mitigation, impacts to marine species would be expected to result from physiological and behavioral responses to both the type and strength of the acoustic signature (Viadaet al.,2008). The type and severity of behavioral impacts are more difficult to define due to limited studies addressing the behavioral effects of impulsive sounds on marine mammals. Potential effects from impulsive sound sources can range in severity, ranging from effects such as behavioral disturbance, tactile perception, physical discomfort, slight injury of the internal organs and the auditory system, to mortality (Yelvertonet al.,1973).

Hearing Impairment and Other Physical Effects—Marine mammals exposed to high intensity sound repeatedly or for prolonged periods can experience hearing threshold shift (TS), which is the loss of hearing sensitivity at certain frequency ranges (Kastaket al.,1999; Schlundtet al.,2000; Finneranet al.,2002, 2005). TS can be permanent (PTS), in which case the loss of hearing sensitivity is not recoverable, or temporary (TTS), in which case the animal's hearing threshold would recover over time (Southallet al.,2007). Marine mammals depend on acoustic cues for vital biological functions, (e.g., orientation, communication, finding prey, avoiding predators); thus, TTS may result in reduced fitness in survival and reproduction. However, this depends on both the frequency and duration of TTS, as well as the biological context in which it occurs. TTS of limited duration, occurring in a frequency range that does not coincide with that used for recognition of important acoustic cues, would have little to no effect on an animal's fitness. Repeated sound exposure that leads toTTS could cause PTS. PTS, in the unlikely event that it occurred, would constitute injury, but TTS is not considered injury (Southallet al.,2007). It is unlikely that the project would result in any cases of temporary or especially permanent hearing impairment or any significant non-auditory physical or physiological effects for reasons discussed later in this document. Some behavioral disturbance is expected, but it is likely that this would be localized and short-term because of the short project duration.

Several aspects of the planned monitoring and mitigation measures for this project (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections later in this document) are designed to detect marine mammals occurring near the pile driving to avoid exposing them to sound pulses that might, in theory, cause hearing impairment. In addition, many cetaceans are likely to show some avoidance of the area where received levels of pile driving sound are high enough that hearing impairment could potentially occur. In those cases, the avoidance responses of the animals themselves would reduce or (most likely) avoid any possibility of hearing impairment. Non-auditory physical effects may also occur in marine mammals exposed to strong underwater pulsed sound. It is especially unlikely that any effects of these types would occur during the present project given the brief duration of exposure for any given individual and the planned monitoring and mitigation measures. The following subsections discuss in somewhat more detail the possibilities of TTS, PTS, and non-auditory physical effects.

Temporary Threshold Shift—TTS is the mildest form of hearing impairment that can occur during exposure to a strong sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises, and a sound must be stronger in order to be heard. In terrestrial mammals, TTS can last from minutes or hours to days (in cases of strong TTS). For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals, and none of the published data concern TTS elicited by exposure to multiple pulses of sound. Available data on TTS in marine mammals are summarized in Southallet al.(2007).

Given the available data, the received level of a single pulse (with no frequency weighting) might need to be approximately 186 dB re 1 μPa2-s (i.e., 186 dB sound exposure level [SEL] or approximately 221-226 dB pk-pk) in order to produce brief, mild TTS. Exposure to several strong pulses that each have received levels near 190 dB re 1 μPa rms (175-180 dB SEL) might result in cumulative exposure of approximately 186 dB SEL and thus slight TTS in a small odontocete, assuming the TTS threshold is (to a first approximation) a function of the total received pulse energy. Levels greater than or equal to 190 dB re 1 μPa rms are expected to be restricted to radii no more than 5 m (16 ft) from the pile driving. For an odontocete closer to the surface, the maximum radius with greater than or equal to 190 dB re 1 μPa rms would be smaller.

The above TTS information for odontocetes is derived from studies on the bottlenose dolphin (Tursiops truncatus) and beluga whale (Delphinapterus leucas). There is no published TTS information for other species of cetaceans. However, preliminary evidence from a harbor porpoise exposed to pulsed sound suggests that its TTS threshold may have been lower (Luckeet al.,2009). To avoid the potential for injury, NMFS has determined that cetaceans should not be exposed to pulsed underwater sound at received levels exceeding 180 dB re 1 μPa rms. As summarized above, data that are now available imply that TTS is unlikely to occur unless odontocetes are exposed to pile driving pulses stronger than 180 dB re 1 μPa rms.

Permanent Threshold Shift—When PTS occurs, there is physical damage to the sound receptors in the ear. In severe cases, there can be total or partial deafness, while in other cases the animal has an impaired ability to hear sounds in specific frequency ranges (Kryter, 1985). There is no specific evidence that exposure to pulses of sound can cause PTS in any marine mammal. However, given the possibility that mammals close to pile driving activity might incur TTS, there has been further speculation about the possibility that some individuals occurring very close to pile driving might incur PTS. Single or occasional occurrences of mild TTS are not indicative of permanent auditory damage, but repeated or (in some cases) single exposures to a level well above that causing TTS onset might elicit PTS.

Relationships between TTS and PTS thresholds have not been studied in marine mammals but are assumed to be similar to those in humans and other terrestrial mammals. PTS might occur at a received sound level at least several decibels above that inducing mild TTS if the animal were exposed to strong sound pulses with rapid rise time. Based on data from terrestrial mammals, a precautionary assumption is that the PTS threshold for impulse sounds (such as pile driving pulses as received close to the source) is at least 6 dB higher than the TTS threshold on a peak-pressure basis and probably greater than 6 dB (Southallet al.,2007). On an SEL basis, Southallet al.(2007) estimated that received levels would need to exceed the TTS threshold by at least 15 dB for there to be risk of PTS. Thus, for cetaceans, Southallet al.(2007) estimate that the PTS threshold might be an M-weighted SEL (for the sequence of received pulses) of approximately 198 dB re 1 μPa2-s (15 dB higher than the TTS threshold for an impulse). Given the higher level of sound necessary to cause PTS as compared with TTS, it is considerably less likely that PTS could occur.

Measured source levels from impact pile driving can be as high as 214 dB re 1 μPa at 1 m (3.3 ft). Although no marine mammals have been shown to experience TTS or PTS as a result of being exposed to pile driving activities, captive bottlenose dolphins and beluga whales exhibited changes in behavior when exposed to strong pulsed sounds (Finneranet al.,2000, 2002, 2005). The animals tolerated high received levels of sound before exhibiting aversive behaviors. Experiments on a beluga whale showed that exposure to a single watergun impulse at a received level of 207 kPa (30 psi) p-p, which is equivalent to 228 dB p-p re 1 μPa, resulted in a 7 and 6 dB TTS in the beluga whale at 0.4 and 30 kHz, respectively. Thresholds returned to within 2 dB of the pre-exposure level within four minutes of the exposure (Finneranet al.,2002). Although the source level of pile driving from one hammer strike is expected to be much lower than the single watergun impulse cited here, animals being exposed for a prolonged period to repeated hammer strikes could receive more sound exposure in terms of SEL than from the single watergun impulse (estimated at 188 dB re 1 μPa2-s) in the aforementioned experiment (Finneranet al.,2002). However, in order for marine mammals to experience TTS or PTS, the animals have to be close enough to be exposed to high intensity sound levels for a prolonged period of time. Based on the best scientific information available, these SPLs are far below the thresholds that could cause TTS or the onset of PTS.

Non-auditory Physiological Effects—Non-auditory physiological effects orinjuries that theoretically might occur in marine mammals exposed to strong underwater sound include stress, neurological effects, bubble formation, resonance effects, and other types of organ or tissue damage (Coxet al.,2006; Southallet al.,2007). Studies examining such effects are limited. In general, little is known about the potential for pile driving to cause auditory impairment or other physical effects in marine mammals. Available data suggest that such effects, if they occur at all, would presumably be limited to short distances from the sound source and to activities that extend over a prolonged period. The available data do not allow identification of a specific exposure level above which non-auditory effects can be expected (Southallet al.,2007) or any meaningful quantitative predictions of the numbers (if any) of marine mammals that might be affected in those ways. Marine mammals that show behavioral avoidance of pile driving, including some odontocetes and some pinnipeds, are especially unlikely to incur auditory impairment or non-auditory physical effects.

Disturbance Reactions

Disturbance includes a variety of effects, including subtle changes in behavior, more conspicuous changes in activities, and displacement. Behavioral responses to sound are highly variable and context-specific and reactions, if any, depend on species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day, and many other factors (Richardsonet al.,1995; Wartzoket al.,2003/2004; Southallet al.,2007).

Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzoket al.,2003/04). Animals are most likely to habituate to sounds that are predictable and unvarying. The opposite process is sensitization, when an unpleasant experience leads to subsequent responses, often in the form of avoidance, at a lower level of exposure. Behavioral state may affect the type of response as well. For example, animals that are resting may show greater behavioral change in response to disturbing sound levels than animals that are highly motivated to remain in an area for feeding (Richardsonet al.,1995; NRC, 2003; Wartzoket al.,2003/04).

Controlled experiments with captive marine mammals showed pronounced behavioral reactions, including avoidance of loud sound sources (Ridgwayet al.,1997; Finneranet al.,2003). Observed responses of wild marine mammals to loud pulsed sound sources (typically seismic guns or acoustic harassment devices, but also including pile driving) have been varied but often consist of avoidance behavior or other behavioral changes suggesting discomfort (Morton and Symonds, 2002; Thorson and Reyff, 2006; see also Gordonet al.,2004; Wartzoket al.,2003/04; Nowaceket al.,2007). Responses to continuous sound, such as vibratory pile installation, have not been documented as well as responses to pulsed sounds.

With both types of pile driving, it is likely that the onset of pile driving could result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include (Richardsonet al.,1995): Changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where sound sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haul-outs or rookeries). Pinnipeds may increase their haul-out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006). Since pile driving would likely only occur for a few hours a day, over a short period of time, it is unlikely to result in permanent displacement. Any potential impacts from pile driving activities could be experienced by individual marine mammals, but would not be likely to cause population level impacts, or affect the long-term fitness of the species.

The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be expected to be biologically significant if the change affects growth, survival, or reproduction. Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction include:

• Drastic changes in diving/surfacing patterns (such as those thought to be causing beaked whale stranding due to exposure to military mid-frequency tactical sonar);

• Habitat abandonment due to loss of desirable acoustic environment; and

• Cessation of feeding or social interaction.

The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southallet al.,2007).

Auditory Masking

Natural and artificial sounds can disrupt behavior by masking, or interfering with, a marine mammal's ability to hear other sounds. Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher levels. Chronic exposure to excessive, though not high-intensity, sound could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions. Masking can interfere with detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction. If the coincident (masking) sound were man-made, it could be potentially harassing if it disrupted hearing-related behavior. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.

The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. Because sound generated from in-water pile driving is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds made by porpoises. However, lower frequency man-made sounds are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey sound. It may also affect communication signals when they occur near the sound band and thus reduce the communication space of animals (e.g., Clarket al.,2009) and cause increased stress levels (e.g., Footeet al.,2004; Holtet al.,2009).

Masking has the potential to impact species at population, community, or even ecosystem levels, as well as at individual levels. Masking affects both senders and receivers of the signals and can potentially have long-term chroniceffects on marine mammal species and populations. Recent research suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, and that most of these increases are from distant shipping (Hildebrand, 2009). All anthropogenic sound sources, such as those from vessel traffic, pile driving, and dredging activities, contribute to the elevated ambient sound levels, thus intensifying masking. However, the sum of sound from the proposed activities is confined in an area of inland waters (San Diego Bay) that is bounded by landmass; therefore, the sound generated is not expected to contribute to increased ocean ambient sound.

The most intense underwater sounds in the proposed action are those produced by impact pile driving. Given that the energy distribution of pile driving covers a broad frequency spectrum, sound from these sources would likely be within the audible range of marine mammals present in the project area. Impact pile driving activity is relatively short-term, with rapid pulses occurring for approximately fifteen minutes per pile. The probability for impact pile driving resulting from this proposed action masking acoustic signals important to the behavior and survival of marine mammal species is likely to be negligible. Vibratory pile driving is also relatively short-term, with rapid oscillations occurring for approximately one and a half hours per pile. It is possible that vibratory pile driving resulting from this proposed action may mask acoustic signals important to the behavior and survival of marine mammal species, but the short-term duration and limited affected area would result in insignificant impacts from masking. Any masking event that could possibly rise to Level B harassment under the MMPA would occur concurrently within the zones of behavioral harassment already estimated for vibratory and impact pile driving, and which have already been taken into account in the exposure analysis.

Airborne Sound Effects

Marine mammals that occur in the project area could be exposed to airborne sounds associated with pile driving that have the potential to cause harassment, depending on their distance from pile driving activities. Airborne pile driving sound would have less impact on cetaceans than pinnipeds because sound from atmospheric sources does not transmit well underwater (Richardsonet al.,1995); thus, airborne sound would only be an issue for hauled-out pinnipeds in the project area. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon their habitat and move further from the source. Studies by Blackwellet al.(2004) and Moultonet al.(2005) indicate a tolerance or lack of response to unweighted airborne sounds as high as 112 dB peak and 96 dB rms.

Anticipated Effects on Habitat

The proposed activities at NBKB would not result in permanent impacts to habitats used directly by marine mammals, such as haul-out sites, but may have potential short-term impacts to food sources such as forage fish and salmonids. There are no rookeries or major haul-out sites within 10 km, foraging hotspots, or other ocean bottom structure of significant biological importance to marine mammals that may be present in the marine waters in the vicinity of the project area. Therefore, the main impact issue associated with the proposed activity would be temporarily elevated sound levels and the associated direct effects on marine mammals, as discussed previously in this document. The most likely impact to marine mammal habitat occurs from pile driving effects on likely marine mammal prey (i.e., fish) near NBKB and minor impacts to the immediate substrate during installation and removal of piles during the wharf construction project.

Pile Driving Effects on Potential Prey (Fish)

Construction activities would produce both pulsed (i.e., impact pile driving) and continuous (i.e., vibratory pile driving) sounds. Fish react to sounds which are especially strong and/or intermittent low-frequency sounds. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. Hastings and Popper (2005, 2009) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. Additional studies have documented effects of pile driving (or other types of continuous sounds) on fish, although several are based on studies in support of large, multiyear bridge construction projects (e.g., Scholik and Yan, 2001, 2002; Popper and Hastings, 2009). Sound pulses at received levels of 160 dB re 1 μPa may cause subtle changes in fish behavior. SPLs of 180 dB may cause noticeable changes in behavior (Pearsonet al.,1992; Skalskiet al.,1992). SPLs of sufficient strength have been known to cause injury to fish and fish mortality. The most likely impact to fish from pile driving activities at the project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. In general, impacts to marine mammal prey species are expected to be minor and temporary due to the short timeframe for the wharf construction project. However, adverse impacts may occur to a few species of rockfish (bocaccio [Sebastes paucispinis], yelloweye [S. ruberrimus] and canary [S. pinniger] rockfish) and salmon (chinook [Oncorhynchus tshawytscha] and summer run chum) which may still be present in the project area despite operating in a reduced work window in an attempt to avoid important fish spawning time periods. Impacts to these species could result from potential impacts to their eggs and larvae.

Pile Driving Effects on Potential Foraging Habitat

The area likely impacted by the project is relatively small compared to the available habitat in the Hood Canal. Avoidance by potential prey (i.e., fish) of the immediate area due to the temporary loss of this foraging habitat is also possible. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the Hood Canal and nearby vicinity.

Given the short daily duration of sound associated with individual pile driving events and the relatively small areas being affected, pile driving activities associated with the proposed action are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Therefore, pile driving is not likely to have a permanent, adverse effect on marine mammal foraging habitat at the project area.

Proposed Mitigation

In order to issue an incidental take authorization (ITA) under Section 101(a)(5)(D) of the MMPA, we must, where applicable, set forth the permissible methods of taking pursuant to such activity, and other means ofeffecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

Measurements from similar pile driving elsewhere at NBKB were coupled with practical spreading loss to estimate zones of influence (ZOIs; see “Estimated Take by Incidental Harassment”); these values were used to develop mitigation measures for pile driving activities at NBKB. The ZOIs effectively represent the mitigation zone that would be established around each pile to prevent Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition to the measures described later in this section, the Navy would employ the following standard mitigation measures:

(a) Conduct briefings between construction supervisors and crews, marine mammal monitoring team, acoustical monitoring team, and Navy staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

(b) Comply with applicable equipment sound standards and ensure that all construction equipment has sound control devices no less effective than those provided on the original equipment.

(c) For in-water heavy machinery work other than pile driving (using, e.g., standard barges, tug boats, barge-mounted excavators, or clamshell equipment used to place or remove material), if a marine mammal comes within 10 m, operations shall cease and vessels shall reduce speed to the minimum level required to maintain steerage and safe working conditions. This type of work could include the following activities: (1) Movement of the barge to the pile location; (2) positioning of the pile on the substrate via a crane (i.e., stabbing the pile); (3) removal of the pile from the water column/substrate via a crane (i.e., deadpull); or (4) the placement of sound attenuation devices around the piles. For these activities, monitoring would take place from 15 minutes prior to initiation until the action is complete.

Monitoring and Shutdown for Pile Driving

The following measures would apply to the Navy's mitigation through shutdown and disturbance zones:

Shutdown Zone—For all pile driving and removal activities, the Navy will establish a shutdown zone intended to contain the area in which SPLs equal or exceed the 180/190 dB rms acoustic injury criteria. The purpose of a shutdown zone is to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury, serious injury, or death of marine mammals. Radial distances for shutdown zones are shown in Table 4. However, a minimum shutdown zone of 10 m will be established during all pile driving and removal activities, regardless of the estimated zone. These precautionary measures are intended to prevent the already unlikely possibility of physical interaction with construction equipment and to further reduce any possibility of acoustic injury.

Disturbance Zone—Disturbance zones are the areas in which SPLs equal or exceed 160 and 120 dB rms (for pulsed and non-pulsed sound, respectively). Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting incidents of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see “Proposed Monitoring and Reporting”). Nominal radial distances for disturbance zones are shown in Tables 4 and 5. Given the size of the disturbance zone for vibratory pile driving), it is impossible to guarantee that all animals would be observed or to make comprehensive observations of fine-scale behavioral reactions to sound, and only a portion of the zone (e.g., what may be reasonably observed by visual observers stationed within the WRA) would be observed.

In order to document observed incidences of harassment, monitors record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile. If acoustic monitoring is being conducted for that pile, a received SPL may be estimated, or the received level may be estimated on the basis of past or subsequent acoustic monitoring. It may then be determined whether the animal was exposed to sound levels constituting incidental harassment in post-processing of observational and acoustic data, and a precise accounting of observed incidences of harassment created. Therefore, although the predicted distances to behavioral harassment thresholds are useful for estimating incidental harassment for purposes of authorizing levels of incidental take, actual take may be determined in part through the use of empirical data. That information may then be used to extrapolate observed takes to reach an approximate understanding of actual total takes.

Monitoring Protocols—Monitoring would be conducted before, during, and after pile driving activities. In addition, observers shall record all incidences of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven. Observations made outside the shutdown zone will not result in shutdown; that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities would be halted. Monitoring will take place from 15 minutes prior to initiation through 15 minutes post-completion of pile driving activities. Pile driving activities include the time to remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.

The following additional measures apply to visual monitoring:

(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained biologists, with the following minimum qualifications:

• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

• Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);

• Experience or training in the field identification of marine mammals, including the identification of behaviors;

• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and

• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

(2) Prior to the start of pile driving activity, the shutdown zone will be monitored for 15 minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (i.e., must leave of their own volition) and their behavior will be monitored and documented. The shutdown zone may only be declared clear, and pile driving started, when the entire shutdown zone is visible (i.e., when not obscured by dark, rain, fog, etc.). In addition, if such conditions should arise during impact pile driving that is already underway, the activity would be halted.

(3) If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 15 minutes have passed without re-detection of the animal. Monitoring will be conducted throughout the time required to drive a pile.

Sound Attenuation Devices

Bubble curtains shall be used during all impact pile driving. The device will distribute air bubbles around 100 percent of the piling perimeter for the full depth of the water column, and the lowest bubble ring shall be in contact with the mudline for the full circumference of the ring. Testing of the device by comparing attenuated and unattenuated strikes is not possible because of requirements in place to protect marbled murrelets (an ESA-listed bird species under the jurisdiction of the USFWS). However, in order to avoid loss of attenuation from design and implementation errors in the absence of such testing, a performance test of the device shall be conducted prior to initial use. The performance test shall confirm the calculated pressures and flow rates at each manifold ring. In addition, the contractor shall also train personnel in the proper balancing of air flow to the bubblers and shall submit an inspection/performance report to the Navy within 72 hours following the performance test.

Timing Restrictions

In Hood Canal, designated exist timing restrictions for pile driving activities to avoid in-water work when salmonids and other spawning forage fish are likely to be present. The in-water work window is July 16-February 15. The barge mooring project would occur during a portion of that period, from July 16-September 30. During the majority of this timeframe, impact pile driving will only occur starting two hours after sunrise and ending two hours before sunset due to marbled murrelet nesting season. After September 23, in-water construction activities will occur during daylight hours (sunrise to sunset).

Soft Start

The use of a soft-start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from vibratory hammers for fifteen seconds at reduced energy followed by a 30-second waiting period. This procedure is repeated two additional times. However, implementation of soft start for vibratory pile driving during previous pile driving work at NBKB has led to equipment failure and serious human safety concerns. Project staff have reported that, during power down from the soft start, the energy from the hammer is transferred to the crane boom and block via the load fall cables and rigging resulting in unexpected damage to both the crane block and crane boom. This differs from what occurs when the hammer is powered down after a pile is driven to refusal in that the rigging and load fall cables are able to be slacked prior to powering down the hammer, and the vibrations are transferred into the substrate via the pile rather than into the equipment via the rigging. One dangerous incident of equipment failure has already occurred, with a portion of the equipment shearing from the crane and falling to the deck. Subsequently, the crane manufacturer has inspected the crane booms and discovered structural fatigue in the boom lacing and main structural components, which will ultimately result in a collapse of the crane boom. All cranes were new at the beginning of the job. In addition, the vibratory hammer manufacturer has attempted to install dampers to mitigate the problem, without success. As a result of this dangerous situation, the measure will not be required for this project. This information was provided to us after the Navy submitted their request for authorization and is not reflected in that document.

For impact driving, soft start will be required, and contractors will provide an initial set of three strikes from the impact hammer at 40 percent energy, followed by a 30-second waiting period, then two subsequent three strike sets.

We have carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that we prescribe the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals; (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation, including consideration of personnel safety, and practicality of implementation.

Based on our evaluation of the applicant's proposed measures, as well as other measures considered, we have preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

Proposed Monitoring and Reporting

In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that we must, where applicable, set forth “requirementspertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that would result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

Visual Marine Mammal Observations

The Navy will collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All observers will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. The Navy will monitor the shutdown zone and disturbance zone before, during, and after pile driving, with observers located at the best practicable vantage points. Based on our requirements, the Navy would implement the following procedures for pile driving:

• MMOs would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible.

• During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals.

• If the shutdown zones are obscured by fog or poor lighting conditions, pile driving at that location will not be initiated until that zone is visible. Should such conditions arise while impact driving is underway, the activity would be halted.

• The shutdown and disturbance zones around the pile will be monitored for the presence of marine mammals before, during, and after any pile driving or removal activity.

Individuals implementing the monitoring protocol will assess its effectiveness using an adaptive approach. Monitoring biologists will use their best professional judgment throughout implementation and seek improvements to these methods when deemed appropriate. Any modifications to protocol will be coordinated between NMFS and the Navy.

Data Collection

We require that observers use approved data forms. Among other pieces of information, the Navy will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the Navy will attempt to distinguish between the number of individual animals taken and the number of incidences of take. We require that, at a minimum, the following information be collected on the sighting forms:

• Date and time that monitored activity begins or ends;

• Construction activities occurring during each observation period;

• Weather parameters (e.g., percent cover, visibility);

• Water conditions (e.g., sea state, tide state);

• Species, numbers, and, if possible, sex and age class of marine mammals;

• Description of any observable marine mammal behavior patterns, including bearing and direction of travel, and if possible, the correlation to SPLs;

• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

• Locations of all marine mammal observations; and

• Other human activity in the area.

Reporting

A draft report would be submitted to NMFS within 90 working days of the completion of marine mammal monitoring. The report will include marine mammal observations pre-activity, during-activity, and post-activity during pile driving days, and will also provide descriptions of any adverse responses to construction activities by marine mammals and a complete description of all mitigation shutdowns and the results of those actions and a refined take estimate based on the number of marine mammals observed during the course of construction. A final report would be prepared and submitted within 30 days following resolution of comments on the draft report.

Estimated Take by Incidental Harassment

With respect to the activities described here, the MMPA defines “harassment” as: “Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”

All anticipated takes would be by Level B harassment, involving temporary changes in behavior. The proposed mitigation and monitoring measures are expected to minimize the possibility of injurious or lethal takes such that take by Level A harassment, serious injury or mortality is considered discountable. However, as noted earlier, it is unlikely that injurious or lethal takes would occur even in the absence of the planned mitigation and monitoring measures.

If a marine mammal responds to an underwater sound by changing its behavior (e.g., through relatively minor changes in locomotion direction/speed or vocalization behavior), the response may or may not constitute taking at the individual level, and is unlikely to affect the stock or the species as a whole. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on animals or on the stock or species could potentially be significant (Lusseau and Bejder, 2007; Weilgart, 2007). Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound. This practice potentially overestimates the numbers of marine mammals actually subject to disturbance that would correctly be considered a take under the MMPA. For example, during the past ten years, transient killer whales have been observed within the project area twice. On the basis of that information, an estimated amount of potential takes for killer whales is presented here. However, while a pod of killer whales could potentially visit again during the project timeframe, and thus be taken, it is more likely that they would not. Although incidental take of killer whales and Dall's porpoises was authorized for 2011-12 activities at NBKB on the basis of past observations of these species, no such takes were recorded and no individuals of these species were observed. Similarly, estimated actual take levels (observed takes extrapolated to the remainder of unobserved but ensonified area) were significantly less than authorized levels of take for the remaining species.

The project area is not believed to be particularly important habitat for marine mammals, nor is it considered an area frequented by marine mammals, although harbor seals are year-round residents of Hood Canal and sea lions are known to haul-out on submarines and other man-made objects at theNBKB waterfront (although typically at a distance of a mile or greater from the project site). Therefore, behavioral disturbances that could result from anthropogenic sound associated with these activities are expected to affect relatively small numbers of individual marine mammals, although those effects could be recurring over the life of the project if the same individuals remain in the project vicinity.

The Navy has requested authorization for the incidental taking of small numbers of California sea lions, harbor seals, transient killer whales, and harbor porpoises in the Hood Canal that may result from pile driving during construction activities associated with the barge mooring project described previously in this document.

The humpback whale is not expected to occur in the project area, and Steller sea lions are not expected to occur during the project timeframe. The earliest documented occurrence of Steller sea lions at NBKB occurred on September 30, 2010, when five individuals were observed at Delta Pier during daily surveys. During monitoring associated with the 2011 TPP, Steller sea lions were documented as arriving on October 8, but had not previously been regularly observed prior to November.

The takes requested are expected to have no more than a minor effect on individual animals and no effect at the population level for these species. Any effects experienced by individual marine mammals are anticipated to be limited to short-term disturbance of normal behavior or temporary displacement of animals near the source of the sound.

Marine Mammal Densities

For all species, the best scientific information available was used to derive density estimates and the maximum appropriate density value for each species for each site was used in the marine mammal take assessment calculation. These values were derived or confirmed by experts convened to develop such information for use in Navy environmental compliance efforts in the Pacific Northwest (Navy, 2013). For harbor seals, this involved published literature describing harbor seal research conducted in Washington and Oregon as well as more specific counts conducted in Hood Canal (Huberet al.,2001; Jeffrieset al.,2003). The best information available for the remaining species in Hood Canal came from surveys conducted by the Navy at the NBKB waterfront or in the vicinity of the project area.

Beginning in April 2008, Navy personnel have recorded sightings of marine mammals occurring at known haul-outs along the NBKB waterfront, including docked submarines or other structures associated with NBKB docks and piers and the nearshore pontoons of the floating security fence. Sightings of marine mammals within the waters adjoining these locations were also recorded. Sightings were attempted whenever possible during a typical work week (i.e., Monday through Friday), but inclement weather, holidays, or security constraints often precluded surveys. These sightings took place frequently, although without a formal survey protocol. During the surveys, staff visited each of the above-mentioned locations and recorded observations of marine mammals. Surveys were conducted using binoculars and the naked eye from shoreline locations or the piers/wharves themselves. Because these surveys consist of opportunistic sighting data from shore-based observers, largely of hauled-out animals, there is no associated survey area appropriate for use in calculating a density from the abundance data. Data were compiled for the period from April 2008 through November 2011 for analysis in this proposed IHA, and these data provide the basis for take estimation for California sea lions. Other information, including sightings data from other Navy survey efforts at NBKB, is available for this species, but these data provide the most conservative (i.e., highest) local abundance estimates (and thus the highest estimates of potential take).

In addition, vessel-based marine wildlife surveys were conducted according to established survey protocols during July through September 2008 and November through May 2009-10 (Tannenbaumet al.,2009, 2011). Eighteen complete surveys of the nearshore area resulted in observations of four marine mammal species (harbor seal, California sea lion, harbor porpoise, and Dall's porpoise). These surveys operated along pre-determined transects parallel to the shoreline from the nearshore out to approximately 1,800 ft (549 m) from shoreline, at a spacing of 100 yd, and covered the entire NBKB waterfront (approximately 3.9 km2per survey) at a speed of 5 kn or less. Two observers recorded sightings of marine mammals both in the water and hauled out, including date, time, species, number of individuals, age (juvenile, adult), behavior (swimming, diving, hauled out, avoidance dive), and haul-out location. Positions of marine mammals were obtained by recording distance and bearing to the animal with a rangefinder and compass, noting the concurrent location of the boat with GPS, and, subsequently, analyzing these data to produce coordinates of the locations of all animals detected. These surveys resulted in the only observation of a Dall's porpoise near NBKB.

The Navy also conducted vessel-based line transect surveys in Hood Canal on non-construction days during the 2011 TPP in order to collect additional data for species present in Hood Canal. These surveys were primarily detected three marine mammal species (harbor seal, California sea lion, and harbor porpoise), and included surveys conducted in both the main body of Hood Canal, near the project area, and baseline surveys conducted for comparison in Dabob Bay, an area of Hood Canal that is not affected by sound from Navy actions at the NBKB waterfront. The surveys operated along pre-determined transects that followed a double saw-tooth pattern to achieve uniform coverage of the entire NBKB waterfront. The vessel traveled at a speed of approximately 5 kn when transiting along the transect lines. Two observers recorded sightings of marine mammals both in the water and hauled out, including the date, time, species, number of individuals, and behavior (swimming, diving, etc.). Positions of marine mammals were obtained by recording the distance and bearing to the animal(s), noting the concurrent location of the boat with GPS, and subsequently analyzing these data to produce coordinates of the locations of all animals detected. Sighting information for harbor porpoises was corrected for detectability (g(0) = 0.54; Barlow, 1988; Calambokidiset al.,1993; Carrettaet al.,2001). Distance sampling methodologies were used to estimate densities of animals for the data. This information provides the best information for harbor porpoises.

The cetaceans, as well as the harbor seal, appear to range throughout Hood Canal; therefore, the analysis in this proposed IHA assumes that harbor seal, transient killer whale, harbor porpoise, and Dall's porpoise are uniformly distributed in the project area. However, it should be noted that there have been no observations of cetaceans within the floating security barriers at NBKB; these barriers thus appear to effectively prevent cetaceans from approaching the shutdown zones. Although the Navy will implement a precautionary shutdown zone for cetaceans, anecdotal evidence suggests that cetaceans are not at risk of Level A harassment at NBKBeven from louder activities (e.g., impact pile driving). The California sea lion does not appear to utilize most of Hood Canal. The sea lions appear to be attracted to the man-made haul-out opportunities along the NBKB waterfront while dispersing for foraging opportunities elsewhere in Hood Canal. California sea lions were not reported during aerial surveys of Hood Canal (Jeffrieset al.,2000).

Description of Take Calculation

The take calculations presented here rely on the best data currently available for marine mammal populations in the Hood Canal. The formula was developed for calculating take due to pile driving activity and applied to each group-specific sound impact threshold. The formula is founded on the following assumptions:

• All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken;

• An individual can only be taken once during a 24-h period; and,

• There were will be twenty total days of activity.

• Exposures to sound levels above the relevant thresholds equate to take, as defined by the MMPA.

The calculation for marine mammal takes is estimated by:

Exposure estimate = (n * ZOI) * days of total activityWhere:n = density estimate used for each species/seasonZOI = sound threshold ZOI impact area; the area encompassed by all locations where the SPLs equal or exceed the threshold being evaluated

n * ZOI produces an estimate of the abundance of animals that could be present in the area for exposure, and is rounded to the nearest whole number before multiplying by days of total activity.

The ZOI impact area is the estimated range of impact to the sound criteria. The distances specified in Table 3 were used to calculate ZOIs around each pile. All impact pile driving take calculations were based on the estimated threshold ranges assuming attenuation of 8 dB from use of a bubble curtain. The ZOI impact area took into consideration the possible affected area of the Hood Canal from the pile driving site furthest from shore with attenuation due to land shadowing from bends in the canal. Because of the close proximity of some of the piles to the shore, the narrowness of the canal at the project area, and the maximum fetch, the ZOIs for each threshold are not necessarily spherical and may be truncated.

While pile driving can occur any day throughout the in-water work window, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving. Acoustic monitoring conducted as part of the TPP demonstrated that Level B harassment zones for vibratory pile driving are likely to be significantly smaller than the zones estimated through modeling based on measured source levels and practical spreading loss. Also of note is the fact that the effectiveness of mitigation measures in reducing takes is typically not quantified in the take estimation process. Here, we do explicitly account for an assumed level of efficacy for use of the bubble curtain, but not for the soft start associated with impact driving. In addition, equating exposure with response (i.e., a behavioral response meeting the definition of take under the MMPA) is simplistic and conservative assumption. For these reasons, these take estimates are likely to be conservative.

Airborne Sound—No incidents of incidental take resulting solely from airborne sound are likely, as distances to the harassment thresholds would not reach areas where pinnipeds may haul out. Harbor seals can haul out at a variety of natural or manmade locations, but the closest known harbor seal haul-out is at the Dosewallips River mouth (London, 2006) and Navy waterfront surveys and boat surveys have found it rare for harbor seals to haul out along the NBKB waterfront (Agness and Tannenbaum, 2009; Tannenbaumet al.,2009, 2011; Navy, 2010). Individual seals have occasionally been observed hauled out on pontoons of the floating security fence within the restricted areas of NBKB, but this area is not with the airborne disturbance ZOI. The Service Pier is elevated at least twenty feet above the surface of the water and is inaccessible to pinnipeds, and seals have not been observed hauled out on the floating Port Operations pier sections or on the shoreline adjacent to the Service Pier. Sea lions typically haul out on submarines docked at Delta Pier, approximately one mile from the project site.

We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with heads above water. However, these animals would previously have been `taken' as a result of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Multiple incidents of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in increased behavioral disturbance, in either nature or intensity of disturbance reaction. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted.

California Sea Lion—California sea lions occur regularly in the vicinity of the project site from August through mid-June, as determined by Navy waterfront surveys conducted from April 2008 through December 2011 (Table 6). With regard to the range of this species in Hood Canal and the project area, it is assumed on the basis of waterfront observations (Agness and Tannenbaum, 2009; Tannenbaumet al.,2009, 2011) that the opportunity to haul out on submarines docked at Delta Pier is a primary attractant for California sea lions in Hood Canal, as they are not typically observed elsewhere in Hood Canal. Their haul-out sites are not within the largest underwater ZOI, because sound would encounter land before reaching the haul-out site (see Figure 6-2 in the Navy's application). Abundance is calculated as the monthly average of the maximum number observed in a given month, as opposed to the overall average (Table 6). That is, the maximum number of animals observed on any one day in a given month was averaged for 2008-11, providing a monthly average of the maximum daily number observed. The largest monthly average (58 animals) was recorded in November, as was the largest single daily count (81 in 2011). The first California sea lion was observed at NBKB in August 2009, and their occurrence has been increasing since that time (Navy, 2012).

California sea lion density for Hood Canal was calculated to be 0.28 animals/km2for purposes of the Navy Marine Species Density Database (Navy, 2013). However, this density was derived by averaging data collected year-round. This project will occur during the months when California sea lions are the least abundant in Hood Canal, so it is more appropriate to use data collected at the NBKB waterfront during those months (July-September). The highest number of individual California sea lions observed hauled out at NBKB during this timeframe during this time was 33, which occurred at the end of September 2010. Exposures were calculated assuming 33 individuals could be present, and therefore exposedto sound exceeding the behavioral harassment threshold, on each day of pile driving. This methodology is still conservative in that it uses the maximum abundance without considering the much lower observed abundances from July and August (when the majority of project activity is likely to be completed) and assumes that all individuals potentially would be taken on any given day of activity.

Table 6—California Sea Lion Sighting Information From NBKB, April 2008-December 2012MonthNumber of surveysNumber of surveys with animals presentFrequency of presence1Abundance2January47360.7731.0February50430.8638.0March47450.9653.3April67550.8245.4May72580.8129.4June73170.237.4July6110.020.6August65120.182.6September54310.5720.4October65610.9451.8November5656160.2December54440.8149.6Total or average (in-water work period only)180440.247.3Totals (number of surveys) and averages (frequency and abundance) presented for work period (July-September) only. Information from October-June presented for reference.1Frequency is the number of surveys with California sea lions present/number of surveys conducted.2Abundance is calculated as the monthly average of the maximum daily number observed in a given month.

Harbor Seal—Jeffrieset al.(2003) conducted aerial surveys of the harbor seal population in Hood Canal in 1999 for the Washington Department of Fish and Wildlife and reported 711 harbor seals hauled out. The authors adjusted this abundance with a correction factor of 1.53 to account for seals in the water, which were not counted, and estimated that there were 1,088 harbor seals in Hood Canal. The correction factor (1.53) was based on the proportion of time seals spend on land versus in the water over the course of a day, and was derived by dividing one by the percentage of time harbor seals spent on land. These data came from tags (VHF transmitters) applied to harbor seals at six areas (Grays Harbor, Tillamook Bay, Umpqua River, Gertrude Island, Protection/Smith Islands, and Boundary Bay, BC) within two different harbor seal stocks (the coastal stock and the inland waters of WA stock) over four survey years. The Hood Canal population is part of the inland waters stock, and while not specifically sampled, Jeffrieset al.(2003) found the VHF data to be broadly applicable to the entire stock. The tagging research in 1991 and 1992 conducted by Huberet al.(2001) and Jeffrieset al.(2003) used the same methods for the 1999 and 2000 survey years. These surveys indicated that approximately 35 percent of harbor seals are in the water versus hauled out on a daily basis (Huberet al.,2001; Jeffrieset al.,2003). Exposures were calculated using a density derived from the number of harbor seals that are present in the water at any one time (35 percent of 1,088, or approximately 381 individuals), divided by the area of the Hood Canal (358.44 km2) and the formula presented previously. The aforementioned area of Hood Canal represents a change from that cited previously for authorizations associated with Navy activities in Hood Canal, and represents a correction to our understanding of the methodology used inJeffries et al.(2003).

We recognize that over the course of the day, while the proportion of animals in the water may not vary significantly, different individuals may enter and exit the water. However, fine-scale data on harbor seal movements within the project area on time durations of less than a day are not available. Previous monitoring experience from Navy actions conducted from in the same project area has indicated that this density provides an appropriate estimate of potential exposures. However, the density of harbor seals calculated in this manner (1.06 animals/km2) is corroborated by results of the Navy's vessel-based marine mammal surveys at NBKB in 2008 and 2009-10, in which an average of five individual harbor seals per survey was observed in the 3.9 km2survey area (density = 1.3 animals/km2) (Tannenbaumet al.,2009, 2011).

Killer Whales—Transient killer whales are uncommon visitors to Hood Canal, and may be present anytime during the year. Transient pods (six to eleven individuals per event) were observed in Hood Canal for lengthy periods of time (59-172 days) in 2003 (January-March) and 2005 (February-June), feeding on harbor seals (London, 2006). These whales used the entire expanse of Hood Canal for feeding. West Coast transient killer whales most often travel in small pods (Baird and Dill 1996). Houghton reported to the Navy, from unpublished data, that the most commonly observed group size in Puget Sound (defined as from Admiralty Inlet south and up through Skagit Bay) from 2004-2010 data is six whales.

The density value derived for the Navy Marine Species Density Database is 0.0019 animals/km2(Navy, 2013), which would result in a prediction that zero animals would be harassed by the project activities. However, while transient killer whales are rare in the Hood Canal, it is possible that a pod of animals could be present. In the event that this occurred, the animals would not assume a uniform distribution as is implied by the density estimate. Therefore, we conservatively assume that a single pod of whales (defined as six whales) could be present in the vicinity of the project for the entire duration.

Dall's Porpoise

Dall's porpoises may be present in the Hood Canal year-round and could occur as far south as the project site. Their use of inland Washington waters, however,is mostly limited to the Strait of Juan de Fuca. One individual has been observed by Navy staff in deeper waters of Hood Canal (Tannenbaumet al.,2009, 2011). The Navy Marine Species Density Database assumes a negligible value of 0.001 animals/1,000 km2for Dall's porpoises in the Hood Canal, which represents species that have historically been observed in an area but have no regular presence. Use of this density value results in a prediction that zero animals would be exposed to sound above the behavioral harassment threshold, and the Navy is not requesting any take authorization for Dall's porpoises.

Harbor Porpoise

During vessel-based line transect surveys on non-construction days during the TPP, harbor porpoises were frequently sighted within several kilometers of the base, mostly to the north or south of the project area, but occasionally directly across from the Bangor waterfront on the far side of Toandos Peninsula. Harbor porpoise presence in the immediate vicinity of the base (i.e., within 1 km) remained low. These data were used to generate a density for Hood Canal. Based on guidance from other line transect surveys conducted for harbor porpoises using similar monitoring parameters (e.g., boat speed, number of observers) (Barlow, 1988; Calambokidiset al.,1993; Carettaet al.,2001), the Navy determined the effective strip width for the surveys to be one kilometer, or a perpendicular distance of 500 m from the transect to the left or right of the vessel. The effective strip width was set at the distance at which the detection probability for harbor porpoises was equivalent to one, which assumes that all individuals on a transect are detected. Only sightings occurring within the effective strip width were used in the density calculation. By multiplying the trackline length of the surveys by the effective strip width, the total area surveyed during the surveys was 471.2 km2. Thirty-eight individual harbor porpoises were sighted within this area, resulting in a density of 0.0806 animals per km2. To account for availability bias, or the animals which are unavailable to be detected because they are submerged, the Navy utilized a g(0) value of 0.54, derived from other similar line transect surveys (Barlow, 1988; Calambokidiset al.,1993; Carrettaet al.,2001). This resulted in a corrected density of 0.149 harbor porpoises per km2. For comparison, 274.27 km2of trackline survey effort in nearby Dabob Bay produced a corrected density estimate of 0.203 harbor porpoises per km2.

California sea lion40.280660Harbor seal1.060341Killer whale0.00190120Dall's porpoise0.00000100Harbor porpoise0.1490401Acoustic injury threshold for impact pile driving is 190 dB for pinnipeds and 180 dB for cetaceans.2Impact pile driving would always occur on the same day as vibratory pile driving, and the 160-dB acoustic harassment zone associated with impact pile driving is considered subsumed by the 120-dB harassment zone produced by vibratory driving. Therefore, takes are not calculated separately for the two zones.4An maximum abundance estimate of 33 animals present per day during the project timeframe was used for take estimation.

Potential takes could occur if individuals of these species move through the area on foraging trips when pile driving is occurring. Individuals that are taken could exhibit behavioral changes such as increased swimming speeds, increased surfacing time, or decreased foraging. Most likely, individuals may move away from the sound source and be temporarily displaced from the areas of pile driving. Potential takes by disturbance would likely have a negligible short-term effect on individuals and not result in population-level impacts.

Negligible Impact and Small Numbers Analyses and Preliminary Determinations

NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” In making a negligible impact determination, we considers a variety of factors, including but not limited to: (1) The number of anticipated mortalities; (2) the number and nature of anticipated injuries; (3) the number, nature, intensity, and duration of Level B harassment; and (4) the context in which the take occurs.

Pile driving activities associated with the barge mooring project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the proposed activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from airborne or underwater sounds generated from pile driving. No mortality, serious injury, or Level A harassment is anticipated given the methods of installation and measures designed to minimize the possibility of injury to marine mammals and Level B harassment would be reduced to the level of least practicable adverse impact. Specifically, vibratory hammers, which do not have significant potential to cause injury to marine mammals due to the relatively low source levels (less than 190 dB), would be the primary method of installation. Also, no impact pile driving will occur without the use of a sound attenuation system (e.g., bubble curtain), and pile driving will either not start or be halted if marine mammals approach the shutdown zone. The pile driving activities analyzed here are similar to other similar construction activities, including recent projects conducted by the Navy in the Hood Canal as well as work conducted in 2005 for the Hood Canal Bridge (SR-104) by the Washington Department of Transportation, which have taken place with no reported injuries or mortality to marine mammals.

The proposed numbers of animals authorized to be taken for California sea lions, harbor seals, and harbor porpoise would be considered small relative to the relevant stocks or populations (each less than five percent) even if each estimated taking occurred to a new individual—an extremely unlikely scenario. For transient killer whales, we estimate take based on an assumption that a single pod of whales, comprising six individuals, is present in the vicinity of the project area for the entire duration of the project. These six individuals represent a small number of transient killer whales. For pinnipeds, no rookeries are present in the project area, there are no haul-outs other than those provided opportunistically by man-made objects, and the project area is not known to provide foraging habitat of any special importance.

Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in viability, and thus would not result in any adverse impact to the stock as a whole in terms of adverse effects on rates of recruitment or survival. The potential for multiple exposures of a small portion of the overall stock to levels associated with Level B harassment in this area is expected to have a negligible impact on the affected stocks.

We have preliminarily determined that the impact of the previously described project may result, at worst, in a temporary modification in behavior (Level B harassment) of small numbers of marine mammals. No mortality or injuries are anticipated as a result of the specified activity, and none are proposed to be authorized. Additionally, animals in the area are not expected to incur hearing impairment (i.e., TTS or PTS) or non-auditory physiological effects. For pinnipeds, the absence of any major rookeries and only a few isolated and opportunistic haul-out areas near or adjacent to the project site means that potential takes by disturbance would have an insignificant short-term effect on individuals and would not result in population-level impacts. Similarly, for cetacean species the absence of any known regular occurrence adjacent to the project site means that potential takes by disturbance would have an insignificant short-term effect on individuals and would not result in population-level impacts. Due to the nature, degree, and context of behavioral harassment anticipated, the activity is not expected to impact rates of recruitment or survival.

For reasons stated previously in this document, the negligible impact determination is also supported by the likelihood that marine mammals are expected to move away from a sound source that is annoying prior to its becoming potentially injurious, and the likelihood that marine mammal detection ability by trained observers is high under the environmental conditions described for Hood Canal, enabling the implementation of shutdowns to avoid injury, serious injury, or mortality. As a result, no take by injury or death is anticipated, and the potential for temporary or permanent hearing impairment is very low and would be avoided through the incorporation of the proposed mitigation measures.

While the numbers of marine mammals potentially incidentally harassed would depend on the distribution and abundance of marine mammals in the vicinity of the survey activity, the numbers are estimated to be small relative to the affected species or population stock sizes, and have been mitigated to the lowest level practicable through incorporation of the proposed mitigation and monitoring measures mentioned previously in this document. This activity is expected to result in a negligible impact on the affected species or stocks. No species for which take authorization is requested are either ESA-listed or considered depleted under the MMPA. No take would be authorized for humpback whales, Steller sea lions, southern resident killer whales, or Dall's porpoises, and the Navy would take appropriate action to avoid unauthorized incidental take should one of these species be observed in the project area.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, we preliminarily find that the proposed barge mooring project would result in the incidental take of small numbers of marine mammals, by Level B harassment only, and that the total taking from the activity would have a negligible impact on the affected species or stocks.

Impact on Availability of Affected Species for Taking for Subsistence Uses

No tribal subsistence hunts are held in the vicinity of the project area; thus, temporary behavioral impacts to individual animals will not affect any subsistence activity. Further, no population or stock level impacts to marine mammals are anticipated or authorized. As a result, no impacts to the availability of the species or stock to the Pacific Northwest treaty tribes are expected as a result of the activities. Therefore, no relevant subsistence uses of marine mammals are implicated by this action.

Endangered Species Act (ESA)

There are no ESA-listed marine mammals expected to occur in the action area during the proposed action timeframe; therefore, no consultation under the ESA is required for such species.

National Environmental Policy Act (NEPA)

The Navy has prepared a draft EA, which has been posted on the NMFS Web site (seeADDRESSES) concurrently with the publication of this proposed IHA and public comments have been solicited. We will review the draft EA and the public comments received and subsequently either adopt it or prepare our own NEPA document before making a determination on the issuance of an IHA.

Proposed Authorization

As a result of these preliminary determinations, we propose to authorize the take of marine mammals incidental to the Navy's barge mooring project, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Agency:United States Patent and Trademark Office (USPTO).

Title:Grace Period Study.

Form Number(s):None.

Agency Approval Number:0651-00xx.

Type of Request:New information collection.

Burden:71 hours annually.

Number of Respondents:420 responses per year. Out of a sample size of 3,000, the USPTO estimates that 420 completed surveys will be received, for a response rate of 14%. The USPTO estimates that none of these surveys will be submitted by small entities.

Avg. Hours Per Response:The USPTO estimates that it will take the public approximately 10 minutes (0.17 hours) to complete this survey. This estimated time includes reading the instructions for the survey, gathering the necessary information, completing the survey, and submitting it to the USPTO.

Needs and Uses:The Grace Period Study survey is used by foreign governments, researchers, and other stakeholders to evaluate the effects of premature disclosure of patentable inventions or ideas on researchers' failures to apply for or receive patents. The USPTO will use the survey to gather data to estimate the value of lost commercial opportunities in Europe due to the lack of adequate patent grace periods in many European countries.

Affected Public:Businesses or other for-profits and non-profit institutions.

Written comments and recommendations for the proposed information collection should be sent on or before June 21, 2013 to Nicholas A. Fraser, OMB Desk Officer, via email toNicholas_A._Fraser@omb.eop.gov,or by fax to 202-395-5167, marked to the attention of Nicholas A. Fraser.

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during March 2013, it issued orders granting authority to import and export natural gas and liquefied natural gas and vacating prior authority. These orders are summarized in the attached appendix and may be found on the FE Web site athttp://www.fossil.energy.gov/programs/gasregulation/authorizations/Orders-2012.html. They are also available for inspection and copying in the Office of Fossil Energy, Office of Natural Gas Regulatory Activities, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

The Commission's regulations include a methodology for oil pipelines to change their rates through use of an index system that establishes ceiling levels for such rates. The Commission bases the index system, found at 18 CFR 342.3, on the annual change in the Producer Price Index for Finished Goods (PPI-FG), plus two point six five percent (PPI-FG + 2.65). The Commission determined in an “Order Establishing Index For Oil Price Change Ceiling Levels” issued December 16, 2010, that PPI-FG + 2.65 is the appropriate oil pricing index factor for pipelines to use for the five-year period commencing July 1, 2011.1

1133 FERC ¶ 61,228 at P 1 (2010).

The regulations provide that the Commission will publish annually, an index figure reflecting the final change in the PPI-FG, after the Bureau of Labor Statistics publishes the final PPI-FG in May of each calendar year. The annual average PPI-FG index figures were 190.5 for 2011 and 194.2 for 2012.2Thus, the percent change (expressed as a decimal) in the annual average PPI-FG from 2011 to 2012, plus 2.65 percent, is positive 0.045923.3Oil pipelines must multiply their July 1, 2012, through June 30, 2013, index ceiling levels by positive 1.0459234to compute their index ceiling levels for July 1, 2013, through June 30, 2014, in accordance with 18 CFR 342.3(d). For guidance in calculating the ceiling levels for each 12 month period beginning January 1, l995,5see Explorer Pipeline Company,71 FERC ¶ 61,416 at n.6 (1995).

2Bureau of Labor Statistics (BLS) publishes the final figure in mid-May of each year. This figure is publicly available from the Division of Industrial Prices and Price Indexes of the BLS, at 202-691-7705, and in print in August in Table 1 of the annual data supplement to the BLS publication Producer Price Indexes via the Internet athttp://www.bls.gov/ppi/home.htm.To obtain the BLS data, scroll down to “PPI Databases” and click on “Top Picks” of the Commodity Data including stage-of-processing indexes (Producer Price Index—PPI). At the next screen, under the heading “Producer Price Index Commodity Data,” select the first box, “Finished goods—WPUSOP3000,” then scroll all the way to the bottom of this screen and click on Retrieve data.

3[194.2−190.5]/190.5 = 0.019423 + 0.0265 = 0.045923.

41 + 0.045923 = 1.045923.

5For a listing of all prior multipliers issued by the Commission, see the Commission's Web site,http://www.ferc.gov/industries/oil/gen-info/pipeline-index.asp.

In addition to publishing the full text of this Notice in theFederal Register,the Commission provides all interested persons an opportunity to view and/or print this Notice via the Internet through FERC's Home Page(http://www.ferc.gov)and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC 20426. The full text of this Notice is available on FERC's Home Page at the eLibrary link. To access this document in eLibrary, type the docket number excluding the last three digits ofthis document in the docket number field and follow other directions on the search page.

User assistance is available for eLibrary and other aspects of FERC's Web site during normal business hours. For assistance, please contact the Commission's Online Support at 1-866-208-3676 (toll free) or 202-502-6652 (email atFERCOnlineSupport@ferc.gov), or the Public Reference Room at 202-502-8371, TTY 202-502-8659. EMail the Public Reference Room atpublic.referenceroom@ferc.gov.

All documents may be filed electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site athttp://www.ferc.gov/docs-filing/efiling.asp.Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system athttp://www.ferc.gov/docs-filing/ecomment.asp.You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support atFERCOnlineSupport@ferc.govor toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, mail an original and seven copies to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. Please include the project number (P-2146-139) on any comments or motions filed.

The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

k.Description of Application:Alabama Power Company (licensee) requests Commission approval to permit existing and proposed facilities associated with a recreational vehicle (RV) park operated by Clear Creek Cove, LLC (permittee) on Lake Logan Martin. The RV park consists of approximately 15.5 acres of land owned by the permittee, 6.7 acres of which is located inside the project boundary on lands over which the licensee holds flowage rights. The licensee previously permitted the construction of 5 docks with associated concrete access pads and a playground inside the project boundary. Inside the project boundary, the permittee also has constructed 11 RV pads with utility connections (81 additional pads are located outside of the project boundary), a swimming beach, and portions of an on-site sewage disposal system. The licensee proposes to permit the above improvements, as well as allow the permittee to make the following additional improvements: (1) Install four boat docks measuring 8 feet by 150 feet; (2) re-configure an existing boat dock; (3) re-purpose an existing boat dock into a floating pavilion; (4) install a boat ramp; (5) construct a parking area and access road; (6) install two additional covered pavilions and a playground on land; and (7) install a walking and cart path. After the proposed improvements, the RV park could accommodate a total of 88 watercraft.

l.Locations of the Application:A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site athttp://www.ferc.govusing the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field (P-2146) to access the document. You may also register online athttp://www.ferc.gov/docs-filing/esubscription.aspto be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or emailFERCOnlineSupport@ferc.gov,for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

n.Comments, Protests, or Motions to Intervene:Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

o.Filing and Service of Documents:Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.

All documents may be filed electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site athttp://www.ferc.gov/docs-filing/efiling.asp.Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system athttp://www.ferc.gov/docs-filing/ecomment.asp.You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support atFERCOnlineSupport@ferc.govor toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, mail an original and seven copies to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. Please include the project number (P-349-177) on any comments or motions filed.

The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

k.Description of Application:Alabama Power Company requests Commission approval to permit The Village, LLC (permittee) to construct certain non-project uses of project lands and waters associated with a residential development at Lake Martin. The proposal would allow the permittee to construct a vehicular bridge, 776 feet of seawall around the island, and three multi-slip boat docks to accommodate 42 watercraft. Approximately 290 feet of riprap and 158 feet of natural swimming beach currently exist along the island's shoreline, and would not be affected by the proposal. To mitigate for the construction of the seawall and bridge abutments, the permittee would be required to develop an additional mitigation plan and install 20 shallow-water fish spawning structures in consultation with the Alabama Department of Conservation and Natural Resources. The vehicular bridge would allow the permittee to construct portions of a residential development on the island, which is owned by the permittee and located outside of the project boundary. The proposed boat docks would serve residents of the development whose lots are located on the island as well as off-water lots.

l.Locations of the Application:A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site athttp://www.ferc.govusing the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field (P-349) to access the document. You may also register online athttp://www.ferc.gov/docs-filing/esubscription.aspto be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or emailFERCOnlineSupport@ferc.gov,for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

n.Comments, Protests, or Motions to Intervene:Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

o.Filing and Service of Documents:Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

Description:Consumers Energy Company and CMS Energy Resource Management Company's Amendment to March 1, 2013 Application of the for Waiver of Affiliate Restrictions Related to the 2016 Planning Year Auction for Capacity.

Filed Date:5/14/13.

Accession Number:20130514-5141.

Comments Due:5 p.m. ET 5/28/13.

Docket Numbers:ER13-1258-002.

Applicants:Land O'Lakes, Inc.

Description:Inquiry Response to be effective 6/14/2013.

Filed Date:5/15/13.

Accession Number:20130515-5000.

Comments Due:5 p.m. ET 6/5/13.

Docket Numbers:ER13-1378-002.

Applicants:Southwest Power Pool, Inc.

Description:Amendment—Docket ER13-1378—City of Coffeyville. Stated Rate to be effective 7/1/2013.

Filed Date:5/15/13.

Accession Number:20130515-5067.

Comments Due:5 p.m. ET 6/5/13.

Docket Numbers:ER13-1492-000.

Applicants:Pacific Gas and Electric Company.

Description:Sacramento Municipal Utility District Fringe Area Service Agreement to be effective 7/1/2013.

Filed Date:5/15/13.

Accession Number:20130515-5001.

Comments Due:5 p.m. ET 6/5/13.

Docket Numbers:ER13-1493-000.

Applicants:Public Service Company of New Mexico.

Description:Modification to OATT Section 2.2 to be effective 7/15/2013.

Take notice that the Commission received the following electric securities filings:

Docket Numbers:ES13-24-000.

Applicants:Upper Peninsula Power Company.

Description:Application for Authorization to Issue Securities Under Section 204 of the Federal Power Act of Upper Peninsula Power Company.

Filed Date:5/15/13.

Accession Number:20130515-5102.

Comments Due:5 p.m. ET 6/5/13.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

Take notice that on May 14, 2013, pursuant to Rule 207(a)(2) of the Commission's Rules of Practices and Procedure, 18 CFR 385.207(a)(2)(2012), Enterprise TE Products Pipeline Company LLC filed a petition seeking a declaratory order approving priority service, the tariff rate structure, and service request allocation methodology for its proposed Seymour Lateral Extension Project, as more fully described in its petition.

Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link athttp://www.ferc.gov.Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

This filing is accessible on-line athttp://www.ferc.gov,using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please emailFERCOnlineSupport@ferc.gov,or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501et seq.), this document announces that the EPA is planning to submit a request for a renewal Information Collection Request (ICR) to the Office of Management and Budget (OMB). Before submitting the ICR to the OMB for review and approval, the EPA is soliciting comments on specific aspects of the proposed information collection as described below.

DATES:

Comments must be submitted on or before July 22, 2013.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2010-0050, by one of the following methods:

•Hand Delivery:Docket No. EPA-HQ-OAR-2010-0050, Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions:Direct your comments to Docket ID No. EPA-HQ-OAR-2010-0050. The EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line atwww.regulations.gov,including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected throughwww.regulations.govor email. Thewww.regulations.govWeb site is an “anonymous access” system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going throughwww.regulations.gov,your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If the EPA cannot read your comment due to technical difficultiesand cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage athttp://www.epa.gov/epahome/dockets.htm.

The EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OAR-2010-0050 which is available for on-line viewing atwww.regulations.gov,or in person viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the Air and Radiation Docket is 202-566-1742.

Usewww.regulations.govto obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document.

What information is the EPA particularly interested in?

Pursuant to section 3506(c)(2)(A) of the PRA, the EPA specifically solicits comments and information to enable it to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(iii) Enhance the quality, utility, and clarity of the information to be collected; and

(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, the EPA is requesting comments from small businesses (especially those that employ less than 25) on examples of specific additional efforts that the EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for the EPA?

You may find the following suggestions helpful for preparing your comments:

(iii) Provide copies of any technical information and/or data you used that support your views.

(iv) If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

(v) Offer alternative ways to improve the collection activity.

(vi) Make sure to submit your comments by the deadline identified underDATES.

(vii) To ensure proper receipt by the EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, andFederal Registercitation.

What information collection activity or ICR does this apply to?

Affected entities:Entities potentially affected by this action are state, local, and tribal governments that are currently operating and maintaining established ambient air quality networks.

ICR status:This ICR is for a renewal information collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in title 40 of the CFR, after appearing in theFederal Registerwhen approved, are listed in 40 CFR part 9, are displayed either by publication in theFederal Registeror by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract:This ICR includes ambient air monitoring data reporting and recordkeeping activities associated with the 40 CFR part 58 Appendix A, Ambient Air Quality Surveillance Quality Assurance Regulations. These data and information are collected by state, local, and tribal air quality management agencies and reported to the EPA.

The EPA Ambient Air Quality Monitoring Program's quality assurance requirements in 40 CFR part 58, Appendix A, require: “2.6 Gaseous and Flow Rate Audit Standards. Gaseous pollutant concentration standards (permeation devices or cylinders of compressed gas) used to obtain test concentrations for CO, SO2, NO, and NO2must be traceable to either a National Institute of Standards and Technology (NIST) Traceable Reference Material (NTRM), NIST Standard Reference Materials (SRM), and Netherlands Measurement Institute (NMI) Primary Reference Materials (valid as covered by Joint Declaration of Equivalence) or a NIST-certified Gas Manufacturer's Internal Standard (GMIS), certified in accordance with one of the procedures given in reference 4 of this appendix. Vendors advertising certification with the procedures provided in reference 4 of this appendix and distributing gases as “EPA Protocol Gas” must participate in the EPA Protocol Gas Verification Program or not use “EPA” in any form of advertising.”

These requirements give assurance to end users that all specialty gas producers selling EPA Protocol Gases are participants in a program that provides an independent assessment of the accuracy of their gases' certified concentrations. In 2010, the EPA developed an Ambient Air Protocol Gas Verification Program (AA-PGVP) that provides end users with information about participating producers and verification results.

Each year, the EPA will attempt to compare gas cylinders from every specialty gas producer being used by ambient air monitoring organizations. The EPA's Regions 2 and 7 have agreed to provide analytical services for verification of 40 cylinders/lab or 80 cylinders total/year. Cylinders will beverified at a pre-determined time each quarter.

In order to make the appropriate selection, the EPA needs to know what specialty gas producers are being used by the monitoring organizations. Therefore, the EPA needs to survey each primary quality assurance organization every year to collect information on specialty gas producers being used and whether the monitoring organization would like to participate in the verification for the upcoming calendar year.

Burden Statement:The annual public reporting and recordkeeping burden for this collection of information is estimated to average 20 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 20 minutes per response with a cost of $22.15 per year. The total number of respondents is assumed to be 211.

The ICR provides a detailed explanation of the agency's estimate, which is only briefly summarized here:

Estimated total number of potential respondents:211.

Frequency of response:Annual.

Estimated total average number of responses for each respondent:1.

Estimated total annual burden hours:70.3.

Estimated total annual costs:$4674.00.

What is the next step in the process for this ICR?

The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, the EPA will issue anotherFederal Registernotice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed underFOR FURTHER INFORMATION CONTACT.

The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in theFederal Register. Copies of the agreements are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 ortradeanalysis@fmc.gov.

The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engagede novo,or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.

Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act.

Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 7, 2013.

Notice of request for comments regarding an extension to an existing OMB clearance.

SUMMARY:

Under the provisions of the Paperwork Reduction Act, the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding the National Contact Center customer evaluation surveys. In this request, the previously approved surveys have been supplemented with surveys that will temporarily replace those existing surveys for one period of several months. These temporary surveys will allow the National Contact Center to compare its customer service levels to those of private industry contact centers. A notice was published in theFederal Registerat 78 FR 14549, on March 6, 2013. No comments were received.

Instructions:Please submit comments only and cite Information Collection 3090-0278, National Contract Center Evaluation Survey, in all correspondence related to this collection. Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: FAR Desk Officer, OMB, Room 10102, NEOB, Washington, DC 20503. All comments received will be posted without change tohttp://www.regulations.gov,including any personal and/or business confidential information provided.

SUPPLEMENTARY INFORMATION:A. Purpose

This information collection will be used to assess the public's satisfaction with the National Contact Center service, to assist in increasing the efficiency in responding to the public's need for Federal information, and to assess the effectiveness of marketing efforts.

Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.

Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

ACTION:

Notice of request for comments regarding an extension to an existing OMB clearance.

SUMMARY:

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning patents.

DATES:

Submit comments on or before July 22, 2013.

ADDRESSES:

Submit comments identified by Information Collection 9000-0096, Patents, by any of the following methods:

•Regulations.gov: http://www.regulations.gov.Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0096, Patents”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0096, Patents” on your attached document.

Instructions:Please submit comments only and cite Information Collection 9000-0096, Patents, in all correspondence related to this collection. Submit cooments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: FAR Desk Officer, OMB, Room 10102, NEOB, Washington, DC 20503. All comments received will be posted without change tohttp://www.regulations.gov,including any personal and/or business confidential information provided.

The patent coverage in FAR subpart 27.2 requires the contractor to report each notice of a claim of patent or copyright infringement that came to the contractor's attention in connection with performing a Government contract (sections 27.202-1 and 52.227-2).

The contractor is also required to report all royalties anticipated or paid in excess of $250 for the use of patented inventions by furnishing the name and address of licensor, date of license agreement, patent number, brief description of item or component, percentage or dollar rate of royalty per unit, unit price of contract item, and number of units (sections 27.202-5, 52.227-6, and 52.227-9).

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

B. Annual Reporting Burden

The information collection requirement in the FAR remains unchanged for the estimated number of respondents and responses received annually. There is no centralized database in the Federal Government that maintains information regarding notice or claim of patent or copyright infringement, when a response to a solicitation contains costs or charges to royalties or when a contractor submits a statement of royalties paid or required to be paid. Subject matter experts in intellectual property law were consulted to obtain additional information that could result in revised estimates for the public burden. These inquiries yielded no additional information in regards to the respondents or responses on a yearly basis. No public comments were received in prior years that have challenged the validity of the Government's estimates.

Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

ACTION:

Notice of request for public comments regarding an extension to an existing OMB clearance.

SUMMARY:

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning pollution prevention and right-to-know information. A notice was published in theFederal Registerat 77 FR 63803, on October 17, 2012. No comments were received.

DATES:

Submit comments on or before June 21, 2013.

ADDRESSES:

Submit comments identified by Information Collection 9000-0147, Pollution Prevention and Right-to-Know Information by any of the following methods:

•Regulations.gov: http://www.regulations.gov.Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0147, Pollution Prevention and Right-to-Know Information”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0147, Pollution Prevention and Right-to-Know Information” on your attached document.

Instructions:Please submit comments only and cite Information Collection 9000-0147, Pollution Prevention and Right-to-Know Information, in all correspondence related to this collection. Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: FAR Desk Officer, OMB, Room 10102, NEOB, Washington, DC 20503. All comments received will be posted without change tohttp://www.regulations.gov,including any personal and/or business confidential information provided.

As implemented in Federal Acquisition Regulation (FAR) Subpart 23.10, Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, signed on October 5, 2009 (74 FR 52117, October 8, 2009) and Executive Order 13423, Strengthening Federal Environmental, Energy, and Transportation Management, signed on January 24, 2007 (72 FR 3919, January 26, 2007), mandates compliance with right-to-know laws and pollution prevention requirements; implementation of an Environmental Management System (EMSs); and completion of Facility Compliance Audits (FCAs).

This information collection will be accomplished by means of FAR clause 52.223-5. This clause requires that Federal facilities comply with the planning and reporting requirements of the Pollution Prevention Act (PPA) of 1990 (42 U.S.C. 13101-13109) and the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 (42 U.S.C. 11001-11050). Additionally, this clause requires contractors to provide information necessary so that agencies can implement EMSs and complete FCAs at certain Federal facilities.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

B. Annual Reporting Burden

The estimated annual reporting burden is slightly decreased since it was originally published in theFederal Registerat 74 FR 48745, on September 24, 2009. The adjustment is made based on current data and consultation with Federal Government subject matter experts familiar with the requirements under this information collection.

Office of Executive Councils, U.S. General Services Administration (GSA).

ACTION:

Notice.

SUMMARY:

The President's Management Advisory Board (PMAB), a Federal Advisory Committee established in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C., App., and Executive Order 13538, will hold a public meeting on Friday, June 7, 2013.

DATES:

The meeting will be held on Friday, June 7, 2013, beginning at 9 a.m. eastern time, ending no later than 1:30 p.m.

Background:The PMAB was established to provide independent advice and recommendations to the President and the President's Management Council on a wide range of issues related to the development of effective strategies for the implementation of best business practices to improve Federal Government management and operation.

Agenda:The main purpose for this meeting is for the PMAB to discuss the areas of work and focus for 2013 which include Management Innovation and Optimizing Federal Real Estate. In addition, the PMAB will hear reports from federal agency executives detailing the progress being made in adopting and implementing the Board's previous recommendations on the following: Improving Strategic Sourcing; Curbing Improper Payments. More detailed information on these PMAB recommendations can be found on the PMAB Web site (see below).

Meeting Access:The PMAB will convene its meeting in the Eisenhower Executive Office Building, 1650 Pennsylvania Avenue NW., Washington, DC. Due to security, there will be no public admittance to the Eisenhower Building to attend the meeting. However, the meeting is open to thepublic; interested members of the public may view the PMAB's discussion athttp://www.whitehouse.gov/live.Members of the public wishing to comment on the discussion or topics outlined in the Agenda should follow the steps detailed in Procedures for Providing Public Comments below.

Availability of Materials for the Meeting:Please see the PMAB Web site (http://www.whitehouse.gov/administration/advisory-boards/pmab) for any materials available in advance of the meeting and for meeting minutes that will be made available after the meeting. Detailed meeting minutes will be posted within 90 days of the meeting.

Procedures for Providing Public Comments:In general, public statements will be posted on the PMAB Web site (see above). Non-electronic documents will be made available for public inspection and copying in PMAB offices at GSA, Washington, DC 20006, on official business days between the hours of 10 a.m. and 5 p.m. eastern time. You can make an appointment to inspect statements by telephoning 202-208-2387. All statements, including attachments and other supporting materials, received are part of the public record and subject to public disclosure. Any statements submitted in connection with the PMAB meeting will be made available to the public under the provisions of the Federal Advisory Committee Act.

The public is invited to submit written statements for this meeting until 12:30 p.m. eastern time on Thursday, June 6, 2013, by either of the following methods:Electronic or Paper Statements:Submit electronic statements to Mr. Winslow, Designated Federal Officer atscott.winslow@gsa.gov;or send paper statements in triplicate to Mr. Winslow at the PMAB GSA address above.

Dated: May 20, 2013.Stephen Brockelman,Director, Office of Executive Councils, General Services Administration.[FR Doc. 2013-12262 Filed 5-21-13; 8:45 am]BILLING CODE 6820-BR-PDEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and PreventionPartnerships To Advance the National Occupational Research Agenda (NORA)AGENCY:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice of public meeting.

SUMMARY:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: “Partnerships to Advance the National Occupational Research Agenda (NORA)”.

Purpose of the Meeting:The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome.

This meeting will include updates from NIOSH leadership on NORA and on plans for evaluating the second decade of NORA. Brief written updates will be available from approximately half of the NORA Sector Councils on their progress, priorities, and implementation plans to date, likely including the NORA Construction; Manufacturing; Public Safety; Services and Wholesale and Retail Trade Councils. There will be time to ask questions and discuss partnership opportunities.

Status:The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 20). Everyone is encouraged to participate through the Internet (to see the slides) and a teleconference call (capacity 50). Each participant is requested to register for the free meeting by sending an email tonoracoordinator@cdc.govcontaining the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation in-person or by Web meeting (requirements include: computer, Internet connection, and telephone, preferably with `mute' capability). An email confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens who do not register to attend in person on or before June 3, 2013, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility.

Background:NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, seehttp://www.cdc.gov/niosh/nora/about.html.

Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils defined sector-specific strategic plans for conducting research and moving the results into widespread practice. To view the National Sector Agendas, seehttp://www.cdc.gov/niosh/nora/.

Dated: May 13, 2013.John Howard,Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.[FR Doc. 2013-12158 Filed 5-21-13; 8:45 am]BILLING CODE 4163-19-PDEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and PreventionStatement of Organization, Functions, and Delegations of Authority

Part C (Centers for Disease Control and Prevention) of the Statement of Organization Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 78 FR 25743-25746, dated May 2, 2013) is amended to reflect the reorganization of the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

Section C-B, Organization and Functions, is hereby amended as follows:

Revise the functional statement for the Office of the Associate Director for Science (CVJ12), as follows:

Office of the Associate Director for Science (CVJ12). (1) Ensures process consistency for science across the CIOs; (2) facilitates cross-center decision-making regarding science; (3) facilitates communication regarding scientific and programmatic services across the Office of Infectious Diseases (OID); (4) conducts necessary regulatory and ethical reviews for activities involving human participants, including determining whether an activity includes research, includes human subjects, is exempt or requires Institutional Review Board approval, and whether an exception is needed to the Public Health Service HIV policy; (5) reviews funded activities for application of human research regulations; (6) reviews, approves, and tracks research protocols, clinical investigations, and the Food and Drug Administration regulated response activities intended for submission to CDC Human Research Protections Office; (7) coordinates and tracks Office of Management and Budget clearance under the Paperwork Reduction Act; (8) serves as the focal point for the OID for implementing policies and guidelines for the conduct of the peer review of infectious disease extramural research grant proposals and subsequent grant administration; (9) coordinates and conducts in-depth external peer review, objective review including special emphasis panel (SEP) process, and secondary program relevance review of extramural research applications by use of consultant expert panels; (10) makes recommendations to the appropriate infectious disease center director on award selections and staff members serve as the program officials in conjunction with CDC grants management and policy officials to implement and monitor the scientific, technical, and administrative aspects of awards; (11) facilitates scientific collaborations between external and internal investigators; and (12) disseminates and evaluates extramural research progress, findings, and impact.

Delete in its entirety the title and functional statement for the Extramural Research Program Office (CVJ14).

Revise the functional statement for the Office of Management and Program Support (CVJ15), as follows:

Office of Management and Program Support (CVJ15). (1) Helps implement and enforce management and operations policies and guidelines developed by federal agencies, DHHS, and Staff Service Offices (SSO); (2) plans, develops, implements, and provides oversight and quality control for center-wide policies, procedures, and practices for administrative management and acquisition and assistance mechanisms, including contracts, memoranda of agreement, and cooperative agreements; (3) provides management and coordination of NCHHSTP-occupied space and facilities; (4) supplies technical guidance and expertise regarding occupancy and facilities management to emergency situations; (5) provides oversight and management of the distribution, accountability, and maintenance of CDC property and equipment; (6) provides oversight, quality control, and management of NCHHSTP records; (7) serves as lead and primary contact and liaison with relevant SSO on all matters pertaining to the center's procurement needs, policies, and activities; (8) develops, reviews, and implements policies, methods and procedures for NCHHSTP non-research extramural assistance programs; (9) interprets general policy directives, proposed legislation, and appropriation language for implications on management and execution of center's programs; (10) provides consultation and technical assistance to NCHHSTP program officials in the planning, implementation, and administration of assistance programs; (11) develops, coordinates and implements objective review processes, including the SEP process for funding of CDC infectious disease non-research grants and cooperative agreements. (12) oversees the formulation of the NCHHSTP budget and responds to inquiries related to the budget; (13) provides technical information services to facilitate dissemination of relevant public health information and facilitates collaboration with national health activities, CDC components, other agencies and organizations, and foreign governments on international health activities; (14) provides oversight for the programmatic coordination of HIV, STD, viral hepatitis, and TB activities between NCHHSTP and other CIOs; develops recommendations to the CDC Director as the lead CIO for these programs for the distribution of HIV, STD, viral hepatitis, and TB funds CDC-wide; (15) provides guidance and coordination to divisions on cross-divisional negotiated agreements; (16) facilitates state and local cross-divisional issues identification and solutions; (17) in coordination with the Office of Program Planning and Policy Coordination, responds to Congress as needed; (18) serves as NCHHSTP liaison to relevant SSOs for all matters related to financial management; (19) serves as focal point for emergency operations and deployment; (20) manages and coordinates workforce development and succession planning activities within NCHHSTP in collaboration with internal and external partners, and coordinates the recruitment, assignment, technical supervision, and career development of staff with emphasis on developing and supporting diversity initiatives and equal opportunity goals; (21) facilitates the assignment of field staff in accordance with CDC and NCHHSTP priorities and objectives and reassesses the role of NCHHSTP field staff assignees to state and local health jurisdictions; and (22) provides center-wide training to supervisors, managers and team leaders.

Dated: May 15, 2013.Sherri A. Berger,Chief Operating Officer, Centers for Disease Control and Prevention.[FR Doc. 2013-12043 Filed 5-21-13; 8:45 am]BILLING CODE 4160-18-MDEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and PreventionStatement of Organization, Functions, and Delegations of Authority

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 78 FR 27398-27399,dated May 10, 2013) is amended to reorganize the Procurement and Grants Office, Office of the Chief Operating Officer, Office of the Director, Centers for Disease Control and Prevention.

Section C-B, Organization and Functions, is hereby amended as follows: Delete in its entirety the titles and functional statements for Procurement and Grants Office (CAJH) insert the following:

Procurement and Grants Office (CAJH). (1) Advises the Director, Centers for Disease Control and Prevention (CDC), the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), and their staff, and provides leadership and direction for CDC acquisition and assistance activities to improve the public's health; (2) plans and develops CDC-wide policies, procedures, and practices in acquisition and assistance areas to support public health science and programs; (3) obtains research and development, services, equipment, supplies, and construction in support of CDC's public health mission through acquisition processes; (4) awards, administers, and terminates contracts, purchase orders, grants, and cooperative agreements essential to improve public health; (5) maintains a continuing program of reviews, evaluations, inquiries, and oversight activities of CDC-wide acquisitions and assistance to ensure adherence to laws, policies, procedures, regulations, and alignment to CDC's public health goals; and (6) maintains liaison with the Department of Health and Human Services (DHHS), General Services Administration (GSA), Government Accountability Office (GAO), and other federal agencies on acquisition and assistance policies, procedures, and operating matters.

Office of the Director (CAJH1). (1) Provides overall leadership, guidance and coordination in all areas of acquisitions and grants activities on behalf of the CDC; (2) provides overall leadership, guidance and coordination in all areas of the Procurement and Grants Office (PGO) activities in order to support CDC's public health mission; (3) provides leadership, supervision, and management of staff necessary to fully manage the performance of PGO; (4) ensures PGO's policies, processes, requests for information and procedures adhere to all rules and regulations and are in alignment with CDC's public health goals; (5) develops and implements organizational strategic planning goals and objectives that support CDC's public health goals; (6) provides overall budgetary and human resource management, and administrative support; (7) directs and coordinates activities in support of the department's Equal Employment Opportunity Program and employee development; (8) develops, implements, and manages professional development strategy and plan for PGO; (9) develops, implements, and manages recruiting, hiring, retention, and succession strategies; (10) coordinates creation and implementation of operating standards/procedures and processes, and monitors compliance; (11) provides and oversees the delivery of PGO-wide administrative management and support services in the areas of fiscal management, personnel, travel, records management, internal controls, and other administrative services; (12) develops and implements administrative policies, procedures, and operations, as appropriate, for PGO, and prepares special reports and studies, as required, in the administrative management areas; (13) serves as PGO's point of contact on all matters concerning facilities management and space utilization; (14) serves as PGO's coordinator of continuity of operations activities; (15) prepares annual budget formulation and budget justifications; (16) manages PGO's internal acquisition processes; (17) maintains liaison with DIMS, GSA, GAO, and other federal agencies on acquisition and assistance compliance activities; (18) maintains a continuing program of evaluation of PGO-wide internal procedures to ensure adherence to laws, policies, procedures, and regulations and make recommendations for ongoing improvement; (19) coordinates Inspector General and General Accounting Office audit activities; (20) coordinates financial audits and reviews and prioritizes resolution using risk-based approaches; (21) provides professional advice on accounting and cost principles in resolving audit exceptions as they relate to the acquisition and assistance processes; (22) develops an Annual Quality Assurance Plan; (23) provides technical and managerial direction for the development, implementation, and maintenance of grants and contracts systems; (24) manages HHS grants and administrative systems; (25) manages activities related to information security; and (26) ensures implementation of data standards across PGO.

Office of Policy, Performance, and Communications (CAJH13). (1) Provides technical and managerial direction for the development of PGO and CDC-wide policies in the acquisition and assistance areas to support CDC's public health science and programs; (2) participates with senior management in program planning, policy determinations, evaluations, and decisions concerning escalation points for acquisition and assistance; (3) provides leadership, coordination, and collaboration on issues management and triaging, and ensures the process of ongoing issues identification, management, and resolution; (4) conducts policy analysis (including regulatory, legal, economic) and identifies and tracks legislation; (5) provides policy review and clearance of materials; (6) manages and responds to Congressional inquiries (e.g., prepare briefings and hearings, facilitate reports to Congress); (7) identifies and assesses policy best practices and helps diffuse and replicate those practices; (8) identifies emerging or cross-cutting policy issues and serves as a catalyst in advancing action; (9) serves as the focal point for the policy analysis, technical review and final clearance of executive correspondence and policy documents that require approval from the CDC Director, CDC Leadership Team, or officials within DHHS; (10) maintains relations with key organizations and individuals working on grants and contract policies or related legislation; (11) coordinates and manages PGO annual planning activities with the Office of Acquisition Services and the Office of Grants Services; (12) conducts continuing studies and analysis of division activities and provides recommendations on workload efficiency and resource utilization; (13) manages and analyzes complex data, develops queries, reports, and analytic tools; (14) develops and implements PGO organizational performance and provides recommendations on performance improvement; (15) conducts ongoing environmental scans of data systems to evaluate PGO performance; (16) designs studies and conducts analysis to streamline grant and contract business processes and improve data consistency, availability, and accuracy; (17) creates PGO data standards; (18) manages activities and reporting for the CDC Director's Quarterly Performance Review initiative; (19) provides communications support to PGO Director and Deputy Director (e.g., presentations, emails, All Hands meetings); (20) manages the flow of any decision documents and correspondence for signature by PGO and CDC Directors; (21) ensures accurate and consistent information dissemination, including Freedom Of Information Act requests and Executive Secretariat controlled correspondence; (22) ensures consistent application of CDC correspondence standards andstyles; (23) designs, plans, organizes, develops, and implements employee communications activities; (24) provides centralized access to all tools and information held on the Intranet and provides leadership in the development and branding of PGO's Intranet and Internet sites and Web pages; (25) manages and responds to media requests for access to subject matter experts, reports, and publications; and (26) provides leadership, technical assistance, and consultation to PGO in establishing best practices in internal and external business communication and implements external communication strategies to promote and protect the agency's brand.

Office of Acquisition Services (CAJHK). The Office of Acquisition Services (OAS) provides leadership for operations and policies relating to agency-level acquisition functions, directs OAS staff development, and oversees acquisition activity analysis and business decision-making processes in support of the agency's public health mission.

Office of the Director (CAJHK1). (1) Provides overall leadership, guidance and coordination in all areas related to acquisitions; (2) provides leadership, supervision, and management of acquisitions staff; (3) ensures policies, processes, and procedures adhere to all rules and regulations and are in alignment with CDC's public health goals; (4) develops and implements organizational strategic planning goals and objectives; (5) provides budgetary and human resource management and administrative support; (6) develops procedures and guidance to implement CDC or office policies, HHS policies, and rules and regulations; (7) leads the development of contracts policy agendas with federal agencies and organizations; (8) provides cost advisory support to acquisitions activities with responsibility for initiating requests for audits and evaluations and providing recommendations to contracting officer, as required; (9) conducts continuing studies and analysis of acquisition activities; (10) provides technical and managerial direction for the development, implementation, and maintenance of acquisition systems; (11) maintains a continuing program of reviews, evaluations, inquiries and oversight activities of CDC-wide acquisitions to ensure adherence to laws, policies, procedures and regulations and alignment with CDC's public health goals; (12) provides technical and managerial direction for functions related to interagency agreement management and VISA purchase card management; (13) operates CDC's Small and Disadvantaged Business Program, and provides direction and support to various other socioeconomic programs encompassing acquisition and assistance activities; (14) develops formal training in procurement for awardees and CDC staff; (15) develops, implements and manages professional development related to required certifications; and (16) plans and directs all activities related to contract closeout.

Acquisition Branch 1 (CAJHKB). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts the acquisition of services, supplies, equipment, research and development, studies, and data collection for CDC through a variety of contractual mechanisms (competitive and noncompetitive) to support CDC's national and international public health operations, utilizing a wide variety of contract types and pricing arrangements; (2) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (3) participates with top program management in program planning, policy determination, evaluation, and direction concerning acquisition strategies and execution; (4) provides leadership and guidance to CDC project officers and public health program officials; (5) maintains a close working relationship with CDC program office components in carrying out their public health missions; (6) provides leadership, direction, procurement options, and approaches in developing specifications/statements of work and contract awards; (7) reviews statements of work from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and negotiates and issues contracts; (8) directs and controls acquisition planning activities to assure total program needs are addressed and procurements are conducted in a logical, appropriate, and timely sequence; (9) provides continuing surveillance of financial and administrative aspects of acquisition-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) provides technical assistance, where indicated, to improve the management of acquisition-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC program offices and the public; (11) performs contract and purchasing administrative activities including coordination and negotiation of contract modifications, reviewing and approving contractor billings, resolving audit findings, and performing close-out/termination activities; (12) assures that contractor performance is in accordance with contractual commitments; (13) maintains branch's official contract files; (14) identifies and mitigates risks associated with contracts and purchase orders; and (15) provides innovative problem-solving methods in the coordination of international procurement for a wide range plan with public health partners in virtually all major domestic and international health agencies dealing with health priorities/issues, to include resolution of matters with the Department of State.

Acquisition Branch 2 (CAJHKC). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts the acquisition of services, supplies, equipment, research and development, studies, and data collection for CDC through a variety of contractual mechanisms (competitive and noncompetitive) to support CDC's national and international public health operations, utilizing a wide variety of contract types and pricing arrangements; (2) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (3) participates with top program management in program planning, policy determination, evaluation, and directions concerning acquisition strategies and execution; (4) provides leadership and guidance to CDC project officers and public health program officials; (5) maintains a close working relationship with CDC program office components in carrying out their public health missions; (6) provides leadership, direction, procurement options, and approaches in developing specifications/statements of work and contract awards; (7) reviews statements of work from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals and negotiates and issues contracts; (8) directs and controls acquisition planning activities to assure total program needs are addressed and procurements are conducted in a logical, appropriate, and timely sequence; (9) provides continuing surveillance of financial and administrative aspects of acquisition-supported activities to assure compliance with appropriate DHHS and CDC policies and application to publichealth activities; (10) gives technical assistance, where indicated, to improve the management of acquisition-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC program offices and the public; (11) performs contract and purchasing administrative activities including coordination and negotiation of contract modifications, reviewing and approving contractor billings, resolving audit findings, and performing close-out/termination activities; (12) assures that contractor performance is in accordance with contractual commitments; (13) maintains branch's official contract files; and (14) identifies and mitigates risks associated with contracts and purchase orders.

Acquisition Branch 3 (CAJHKD). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts the acquisition of services, supplies, equipment, research and development, studies, and data collection for CDC through a variety of contractual mechanisms (competitive and noncompetitive) to support CDC's national and international public health operations, utilizing a wide variety of contract types and pricing arrangements; (2) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (3) participates with top program management in program planning, policy determination, evaluation, and directions concerning acquisition strategies and execution; (4) provides leadership and guidance to CDC project officers and public health program officials; (5) maintains a close working relationship with CDC program office components in carrying out their public health missions; (6) provides leadership, direction, procurement options, and approaches in developing specifications/statements of work and contract awards; (7) reviews statements of work from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and negotiates and issues contracts; (8) directs and controls acquisition planning activities to assure total program needs are addressed and procurements are conducted in a logical, appropriate, and timely sequence; (9) provides continuing surveillance of financial and administrative aspects of acquisition-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of acquisition-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC program offices and the public; (11) performs contract and purchasing administrative activities including coordination and negotiation of contract modifications, reviewing and approving contractor billings, resolving audit findings, and performing close-out/termination activities; (12) assures that contractor performance is in accordance with contractual commitments; (13) maintains branch's official contract files; (14) identifies and mitigates risks associated with contracts and purchase orders; and (15) plans, directs, and conducts the acquisition of services, institutional support services, architect-engineering services, construction of new buildings, alterations, renovations, commodities, and equipment in support of CDC/ATSDR facilities, utilizing a wide variety of contract types and pricing arrangements.

Acquisition Branch 4 (CAJHKE). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts the acquisition of services, supplies, equipment, research and development, studies, and data collection for CDC through a variety of contractual mechanisms (competitive and non-competitive) to support CDC's national and international public health operations, utilizing a wide variety of contract types and pricing arrangements; (2) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (3) participates with top program management in program planning, policy determination, evaluation, and directions concerning acquisition strategies and execution; (4) provides leadership and guidance to CDC project officers and public health program officials; (5) maintains a close working relationship with CDC program office components in carrying out their public health missions; (6) provides leadership, direction, procurement options, and approaches in developing specifications/statements of work and contract awards; (7) reviews statements of work from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and negotiates and issues contracts; (8) directs and controls acquisition planning activities to assure total program needs are addressed and procurements are conducted in a logical, appropriate, and timely sequence; (9) provides continuing surveillance of financial and administrative aspects of acquisition-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of acquisition-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC program offices and the public; (11) performs contract and purchasing administrative activities including coordination and negotiation of contract modifications, reviewing and approving contractor billings, resolving audit findings, and performing close-out/termination activities; (12) assures that contractor performance is in accordance with contractual commitments; (13) maintains branch's official contract files; (14) identifies and mitigates risks associated with contracts and purchase orders; (15) assures the acquisition functions in support of the center are accomplished with field office locations; and (16) plans and directs all activities related to interagency agreements.

Office of Grants Services (CAJHL). The Office of Grants Services (OGS) provides leadership for operations and policies relating to agency-level grants functions, directs OGS staff development, and oversees grants activity analysis and business decision-making processes in support of the agency's public health mission.

Office of the Director (CAJHL1). (1) Provides overall leadership, guidance and coordination in all areas related to grants; (2) provides leadership, supervision, and management of grants staff; (3) ensures policies, processes, and procedures adhere to all rules and regulations and are in alignment with CDC's public health goals; (4) develops and implements organizational strategic planning goals and objectives; (5) provides budgetary, human resource management and administrative support; (6) develops procedures and guidance to implement CDC, HHS and office policies and rules and regulations; (7) leads the development of grants policy agendas with federal agencies and organizations; (8) provides cost advisory support to assistance activities with responsibility for initiating requests for audits and evaluations, and providing recommendations to grants management officer, as required; (9) conducts continuing studies and analysis of grant activities; (10) providestechnical and managerial direction for the development, implementation, and maintenance of grants systems; (11) provides measures of effectiveness and termination of grants and cooperative agreements; (12) maintains a continuing program of reviews, evaluations, inquiries, and oversight activities of CDC-wide assistance to ensure adherence to laws, policies, procedures, and regulations and alignment with CDC's public health goals; (13) provides technical and managerial direction for functions related to objective review and grants close out; (14) serves as a central CDC receipt and referral point for all applications for assistance funds, including interfacing with the automated grants systems and relevant DHHS line of business agencies and distributing draft public health program announcements for review; (15) develops formal training in grants management for awardees and CDC staff; and (16) develops, implements, and manages professional development related to required certifications.

Infectious Disease Services Branch (CAJHLB). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts assistance management activities for CDC through the awards of grants and cooperative agreements (competitive and non-competitive) across the public health system; (2) plans, directs, coordinates, and conducts the grants managements functions and processes in support of public health assistance awards; (3) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (4) provides leadership, direction, and approaches in developing grants announcements; (5) participates with leadership in program planning, policy determination, evaluation, and directions concerning assistance strategies and execution; (6) provides leadership and guidance to CDC project officers and public health program officials related to grants activities; (7) maintains a close working relationship with CDC program office components in carrying out their public health missions; (8) reviews assistance applications from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and issues grants and cooperative agreements; (9) provides continuing surveillance of financial and administrative aspects of assistance-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of assistance-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC office and the public; (11) assures that grantee performance is in accordance with assistance requirements; (12) provides for the collection and reporting of business management and public health programmatic data, and analyzes and monitors business management data on grants and cooperative agreements; and (13) maintains branch's official assistance files.

Chronic Disease and Birth Defects Services Branch (CAJHLC). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts assistance management activities for CDC through the awards of grants and cooperative agreements (competitive and non-competitive) across the public health system; (2) plans, directs, coordinates, and conducts the grants managements functions and processes in support of public health assistance awards; (3) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (4) provides leadership, direction, and approaches in developing grants announcements; (5) participates with leadership in program planning, policy determination, evaluation, and directions concerning assistance strategies and execution; (6) provides leadership and guidance to CDC project officers and public health program officials related to grants activities; (7) maintains a close working relationship with CDC program office components in carrying out their public health missions; (8) reviews assistance applications from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and issues grants and cooperative agreements; (9) provides continuing surveillance of financial and administrative aspects of assistance-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of assistance-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC office and the public; (11) assures that grantee performance is in accordance with assistance requirements; (12) provides for the collection and reporting of business management and public health programmatic data, and analyzes and monitors business management data on grants and cooperative agreements; and (13) maintains branch's official assistance files.

OD, Environmental, Occupational Health and Injury Prevention Services Branch (CAJHLD). This branch supports one or more centers, and/or offices by performing the following: (1) Plans, directs, and conducts assistance management activities for CDC through the awards of grants and cooperative agreements (competitive and noncompetitive) across the public health system; (2) plans, directs, coordinates, and conducts the grants managements functions and processes in support of public health assistance awards; (3) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (4) provides leadership, direction, and approaches in developing grants announcements; (5) participates with leadership in program planning, policy determination, evaluation, and directions concerning assistance strategies and execution; (6) provides leadership and guidance to CDC project officers and public health program officials related to grants activities; (7) maintains a close working relationship with CDC program office components in carrying out their public health missions; (8) reviews assistance applications from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and issues grants and cooperative agreements; (9) provides continuing surveillance of financial and administrative aspects of assistance-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of assistance-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC office and the public; (11) assures that grantee performance is in accordance with assistance requirements; (12) provides for the collection and reporting of business management and public health programmatic data, and analyzes and monitors business management data on grants and cooperative agreements; (13) maintains branch's official assistance files; and (14) assures public health assistance functions are accomplished with field office locations.

Global Health Services Branch (CAJHLE). This branch supports one or more centers, and/or offices byperforming the following: (1) Plans, directs, and conducts assistance management activities for CDC through the awards of grants and cooperative agreements (competitive and non-competitive) across the public health system; (2) plans, directs, coordinates, and conducts the grants managements functions and processes in support of public health assistance awards; (3) establishes branch goals, objectives, and priorities, and assures their consistency and coordination with the overall objectives of PGO and CDC; (4) provides leadership, direction, and approaches in developing grants announcements; (5) participates with leadership in program planning, policy determination, evaluation, and directions concerning assistance strategies and execution; (6) provides leadership and guidance to CDC project officers and public health program officials related to grants activities; (7) maintains a close working relationship with CDC program office components in carrying out their public health missions; (8) reviews assistance applications from a management point of view for conformity to laws, regulations, and policies and alignment to CDC's public health goals, and issues grants and cooperative agreements; (9) provides continuing surveillance of financial and administrative aspects of assistance-supported activities to assure compliance with appropriate DHHS and CDC policies and application to public health activities; (10) gives technical assistance, where indicated, to improve the management of assistance-supported activities, and responds to requests for management information from the Office of the Director, headquarters, regional staffs, CDC office and the public; (11) assures that grantee performance is in accordance with assistance requirements; (12) provides for the collection and reporting of business management and public health programmatic data, and analyzes and monitors business management data on grants and cooperative agreements; (13) maintains branch's official assistance files; and (14) provides innovative problem-solving methods in the coordination of international grants for a wide range plan with public health partners in virtually all major domestic and international health agencies dealing with health priorities/issues, to include resolution of matters with the Department of State.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in theFederal Registerconcerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic (IVD) tests when a premarket review is not needed.

DATES:

Submit either electronic or written comments on the collection of information by July 22, 2013.

ADDRESSES:

Submit electronic comments on the collection of information tohttp://www.regulations.gov.Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in theFederal Registerconcerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Requests for CLIA Categorization—42 CFR 493.17 (OMB Control Number 0910-0607)—Extension

A guidance document entitled “Guidance for Administrative Procedures for CLIA Categorization” was released on May 7, 2008. The document describes procedures FDA uses to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer because the labeling (including operating instructions) is included in the premarket notification (510(k)) or premarket approval application (PMA). In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g. name change, exempt from 510(k) review). The guidance recommends that in thecorrespondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden1ActivityNumber of

respondents

Number of

responses per respondent

Total annual responsesAverage

burden per

response

Total hoursOperating and maintenance costsRequest for CLIA categorization60159001900$46,800

The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour (52 × 900), totaling $46,800. This includes the cost of copying and mailing copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. The burden hours are based on FDA familiarity with the types of documentation typically included in a sponsor's categorization requests, and costs for basic office supplies (e.g. paper).

The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.

To obtain input from stakeholders about REMS standardization and evaluation, FDA will hold a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS.

DATES:

The meeting will be held on July 25 and 26, 2013, from 8:30 a.m. to 4:30 p.m. Individuals who wish to present at the meeting must register by July 10, 2013. See section IV of this document for information on how to register to speak at the meeting.

ADDRESSES:

The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Submit electronic comments tohttp://www.regulations.gov.Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify each set of comments with the corresponding docket number for the public meeting as follows: “Docket No. FDA-2013-N-0502, “Standardization and Evaluation of Risk Evaluation and Mitigation Strategies, Public Meeting.”

This meeting builds upon prior stakeholder feedback on and input into the design, implementation, and assessment of REMS. In July 2010, FDA held a public meeting to obtain input on issues associated with the development and implementation of REMS. In June 2012, FDA held a public workshop to discuss survey methodologies and instruments that can be used to evaluate patients' and health care providers' knowledge about the risks of drugs marketed with an approved REMS. In addition, the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) requires FDA to bring, at least annually, one or more drugs with REMS with elements to assure safe use (ETASU) before the Drug Safety and Risk Management Advisory Committee. FDA also regularly discusses both pre- and postapproval REMS with ETASUs with various FDA advisory committees in the context of specific applications.

This meeting also builds on FDA's internal efforts to improve the design, implementation and assessment of REMS. In 2011, FDA created the REMS Integration Initiative, designed to evaluate and improve its implementation of REMS authorities. More information about the REMS Integration Initiative can be found at (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm). As part of this effort, FDA seeks to improve future REMS assessments and incorporate the latest methodologies in the evolving science of risk management. In its February 2013 report, “FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety,” the Department of Health and Human Services Office of the Inspector General affirmed the need to identify and implement reliable methods to assess the effectiveness of REMS and REMS components. This report is available athttps://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf.

This public meeting is intended to meet performance goals included in the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V). This reauthorization, part of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) signed by the President on July 9, 2012, includes a number of performance goals and procedures that are documented in the PDUFA VCommitment Letter. (See “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017,” which is available athttp://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.)

FDA developed the performance goals and procedures for PDUFA V in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from July 2010 through May 2011. Title XI of the letter, “Enhancement and Modernization of the FDA Drug Safety System,” states that FDA user fees will be used to enhance REMS by measuring the effectiveness of REMS and evaluating, with stakeholder input, appropriate ways to better integrate them into the existing and evolving health care system. (See “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017” athttp://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf).

Toward that end, the PDUFA V Commitment Letter identified a number of specific goals, including holding one or more public meetings to explore strategies to standardize REMS and reduce the burden of implementing REMS on practitioners, patients, and others in various health care settings and on methodologies for assessing whether REMS are mitigating the risks they purport to mitigate and for assessing the effectiveness and impact of REMS, including methods for assessing the effect on patient access, individual practitioners, and the overall burden on the health care delivery system. FDA also committed to issuing a report of its findings regarding standardizing REMS; the report will identify priority projects in four areas (pharmacy systems, prescriber education, providing benefit/risk information to patients, and practice settings). FDA also committed to issuing guidance on methodologies for assessing REMS, specifically, methodologies for determining whether a specific REMS with ETASU is commensurate with the specific serious risk listed in the labeling of the drug and considering the observed risk, not unduly burdensome on patient access to the drug. For details on specific FDA commitments, see the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 Through 2017, Section XI, “Enhancement and Modernization of the FDA Drug Safety System,” Parts A2, A3, which is available athttp://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.

II. Purpose and Scope of Meeting

The purpose of this public meeting is to obtain feedback from stakeholders on: (1) Issues and challenges associated with standardizing and assessing REMS for drug and biological products and (2) identifying potential projects that will help standardize REMS and integrate them into the health care delivery system. FDA is seeking information and comments from a broad range of stakeholders, including interested health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public.

To promote greater standardization and improved assessment of REMS, FDA is seeking feedback on how to reduce any unnecessary variation in REMS and, in the process, to make REMS elements and associated tools less burdensome to stakeholders, better integrated into the health care system, more effective, and easier to assess. FDA recognizes that the REMS elements and associated tools found in existing REMS programs have varied. In some cases, these variations are appropriate, because REMS are designed to address specific risks posed by particular drugs in a wide range of patient populations and health care settings. However, FDA may be able to establish standards to reduce unnecessary variation and to make REMS more predictable and simpler to understand, implement, and measure. The establishment of standards also presents the opportunity to improve upon the design of REMS elements and associated tools and assessment methodologies in the future.

After this meeting, FDA will issue a report to the public that identifies REMS standardization projects in the four areas specified in the PDUFA V commitment letter: Prescriber education, pharmacy systems, practice settings, and providing benefit/risk information to patients. FDA welcomes stakeholder input to help identify high-quality projects that could offer FDA and stakeholders the opportunity to develop, test, and implement new approaches to standardizing REMS and integrating them into the health care system. The scope of such projects might include research studies, demonstration projects, and the development of new REMS tools using, for example, emerging information technologies or existing controls in the health care system. These projects might be carried out by FDA alone or in collaboration with stakeholders and outside experts.

III. Scope of Public Input Requested

FDA is particularly interested in obtaining information and public comment on the following areas:

A. Prescriber-Directed REMS Tools

REMS programs use a number of tools to educate prescribers and/or ensure that they carry out REMS requirements, including screening, monitoring, and counseling patients. These tools have included risk communications to prescribers, prescriber training, and instruments to help prescribers prescribe the drug safely—for example, counseling guides and checklists.

1. Many REMS with elements to assure safe use provide for prescriber training on the risks of the drug and how to use the drug safely. In some REMS, the completion of this training is required before a person can become a certified prescriber of the drug. Sponsors provide REMS training in a variety of formats, including in-person, online, and through printed materials. FDA is interested in input on which formats and training approaches are most effective for prescriber training; how frequently prescribers should be asked to take REMS training and whether a single training is sufficient; what additional tools could be used to reinforce what prescribers learn during the training and help them apply what they have learned; and how REMS training could be incorporated into continuing medical education programs.

2. Prescriber training often includes knowledge assessments that prescribers must successfully complete as part of the training. These knowledge assessments, which typically take the form of multiple-choice questions, are designed to ensure that the prescriber understands the training material; they also serve to reinforce key messages from the training. (Knowledge assessments should not be confused with the surveys of knowledge that drug manufacturers may conduct as part of their REMS assessments.) FDA is interested in input on when knowledge assessments should be included in REMS and whether they should be included in all REMS that include prescriber training. In addition, FDA requests input on how knowledge assessments can be designed to ensure accurate measurement of prescribers' knowledge and how knowledge assessments can be designed to measure or predict prescribers' ability to apply what they have learned in their practice.

3. Once prescribers have met all requirements for certification under theREMS (e.g., completed training), they generally must complete an enrollment form to be recognized as certified and able to prescribe the drug. Generally, by completing, signing, and submitting the enrollment form, prescribers acknowledge their understanding of the drug's risks and the REMS requirements. In some REMS, the enrollment form also is used to share information about the risks of the drug and how to use the drug safely. FDA is interested in stakeholder input on whether the information and agreements included in current REMS prescriber enrollment forms are presented in a way that is easy for prescribers to understand. Also, what, if anything, should be done to standardize, simplify, or streamline prescriber enrollment forms and the overall prescriber enrollment process?

4. What else can be done to improve the effectiveness of existing prescriber-directed REMS tools, to standardize them, to reduce their burden, and/or to better integrate them into the health care delivery system?

5. What tools and technologies not currently used in REMS could be incorporated into REMS to help educate prescribers and ensure that they carry out REMS requirements? What evidence exists to support the effectiveness of these tools and technologies?

6. What projects could be carried out to standardize the provision of prescriber education in REMS?

7. What projects could be carried out to better integrate REMS into prescriber practice settings?

8. What methodologies exist or might be developed to assess the effectiveness of prescriber-directed REMS tools, the tools' burden on the health care delivery system, and the effect of these tools on patient access?

B. Patient-Directed REMS Tools

REMS programs may use a number of tools to educate and counsel patients, provide patients with information about the risks of the drug, and help to ensure that patients use the drug safely. These tools may include patient enrollment in the REMS, patient monitoring, counseling by health care professionals, Medication Guides, and other patient-directed educational materials.

1. REMS use a range of written materials to help educate and counsel patients, including Medication Guides. In some cases, health care practitioners give these materials to patients to read on their own, and in other cases health care providers are asked to review these materials with patients and use them in patient counseling.

2. In REMS that include patient education, what would make written educational materials more effective? What other materials, tools, and technologies, (e.g., reference materials, checklists, smartphone applications) might be used to help educate patients and reinforce what they have learned?

3. How could the provision of information to patients be standardized, and what are the most efficient ways of providing information to patients given the variety of patient information needs and learning styles?

4. In many REMS, patients receive counseling that may include a discussion of the benefits and risks of the drug as well as instructions on how to use the drug safely. In the majority of such REMS, prescribers are called upon to counsel patients, but other health care practitioners, including pharmacists and nurses, may also play a role in counseling patients. What are ways to improve current REMS approach to counseling patients? How should the timing and frequency of patient counseling be determined? Under what circumstances is it appropriate for prescribers to provide patient counseling in a REMS, when should other providers play a role in counseling patients in a REMS, and how can patient counseling in REMS be integrated into pharmacists' existing medication therapy management practices?

5. Many REMS with elements to assure safe use include prescriber-patient agreements. These agreements are used to document that an informed discussion of the drug's benefits and risks took place and that the patient understood the risks. Prescriber-patient agreements may also support patient counseling by providing information for prescribers to review with patients. Some REMS require that these agreements be signed by the prescriber and patient and submitted to the drug manufacturer. Are the information and agreements included in prescriber-patient agreements presented in a way that is easy for patients to understand and act upon? What, if anything, should be done to standardize, simplify, or streamline prescriber-patient agreement forms and the overall agreement process?

6. What else can be done to improve the effectiveness of existing patient-directed tools, to standardize them, to reduce their burden, and/or to better integrate them into the existing and evolving health care delivery system?

7. What tools and technologies not currently used in REMS could be incorporated into REMS to help counsel patients, to provide them with information on the risks of the drug, and to ensure that they use the drug safely? What evidence exists to support the effectiveness of these tools and technologies?

8. What projects could be carried out to standardize the provision of benefit-risk information to patients?

9. What methodologies exist or might be developed to assess the effectiveness of patient-directed REMS tools, the tools' burden on the health care delivery system, and the effect of these tools on patient access?

C. REMS Tools in Drug Dispensing Settings

Drug dispensing settings, such as prescribers' offices, hospitals, pharmacies (e.g., specialty, retail, and mail-order), integrated health care delivery systems, and infusion centers, often play a significant role in REMS. This is a challenging area to address because of the wide range of health care settings involved and because dispensers are frequently called upon to coordinate care across a range of health care settings and practitioners and to reinforce the tools that have been used by other health care practitioners. Specific dispensing settings may be required to obtain certification under a REMS, and, like prescribers, the health care practitioners who dispense a drug (authorized dispensers) may be required to complete training, counsel patients, and provide patients with educational materials, including Medication Guides. In addition, dispensers may be required to document that certain safe-use conditions are met before dispensing (e.g., by ordering/checking lab tests or completing a form or checklist).

Many REMS with elements to assure safe use require that specific health care settings be certified to be able to dispense the drug. To certify the health care setting, REMS typically require a representative of that health care setting to agree that the health care setting will meet all REMS requirements, including the completion of any necessary training.

1. Under what circumstances should individual practitioners within a health care setting (e.g., pharmacists, as opposed to pharmacies) be certified, instead of the health care setting? How could this effectively be accomplished while minimizing the burden on the health care system?

2. In most REMS that include dispenser certification, each dispensing site is certified individually. Under what circumstances would it be appropriate to use a single certification for a health care setting with multiple dispensing sites such as a pharmacychain, an integrated health care system, or a hospital system?

3. In what ways can the implementation of REMS tools in different dispensing settings be standardized, and under what circumstances might the implementation approach need to vary to accommodate the different types of dispensing settings that can be part of a REMS?

4. What obstacles have made it difficult for authorized dispensers to obtain drugs under existing REMS, and how can these be overcome?

5. How can REMS be made more compatible with existing systems for the procurement and distribution of drugs? How can REMS be integrated into any future electronic track and trace systems?

6. What else can be done to improve the effectiveness of existing REMS tools in drug dispensing settings, to standardize them, to reduce their burden, and/or to better integrate them into the existing and evolving health care delivery system?

7. What tools and technologies not currently used in REMS could be incorporated into REMS to help train and certify authorized dispensers, ensure that only certified dispensers can obtain the drug, and ensure that any safe-use conditions are met before a drug is dispensed? What evidence exists to support the effectiveness of these tools and technologies?

8. What projects could be carried out to integrate REMS tools into pharmacy systems?

9. What projects could be carried out to integrate REMS tools into other drug dispensing settings, such as hospitals, pharmacies, long-term care facilities, and integrated health care delivery systems?

10. What methodologies exist or might be developed to assess the effectiveness of REMS tools across the range of dispensing settings, the tools' burden on the health care delivery system, and the effect of these tools on patient access?

D. Approaches to Standardizing REMS Tools

Many stakeholders have asked FDA to standardize specific REMS tools like stakeholder enrollments, Web sites, and educational materials. Standardizing REMS tools will require ongoing collaboration among FDA, drug manufacturers, stakeholders, scientific experts, and others. To ensure that standardized tools are effective and minimally burdensome, they should be developed in an open and inclusive process that incorporates the feedback of all relevant stakeholders as well as the latest science and best practices from across the health care system. To ensure the continued success of these tools, they must be updated regularly as best practices evolve.

1. What opportunities and barriers exist for the development and implementation of standardized REMS tools? What are some ways that FDA can collaborate with third parties such as standards development organizations, industry groups, professional societies, and accreditation organizations to develop standardized REMS tools and ensure their adoption?

2. How might health information technologies such as electronic health records, pharmacy management systems and electronic prescribing systems be used to integrate REMS into existing health care settings? What role might health information technologies play in REMS in the future? How can these technologies be used to inform practitioners and patients about REMS, monitor patients, and document that any safe-use conditions are met? Could the integration of REMS into health information systems ever reduce or eliminate the need for other REMS tools, such as provider education?

3. Many stakeholders have suggested that a single Web portal should be established to act as a repository for standardized REMS tools and materials and to serve as a central information or reference source for REMS stakeholders. What barriers exist for the development of a single REMS Web portal? Who would be responsible for developing and maintaining the Web portal, and what role would FDA play?

E. Approaches To Assessing the Impact of REMS

Drug manufacturers are required to submit assessments of their REMS on a regular basis. To date, these assessments have tried to evaluate the effectiveness of the REMS by measuring the frequency of adverse outcomes of interest, the knowledge of stakeholders, and the compliance of stakeholders with certain REMS requirements. To accomplish this, drug manufacturers have relied on spontaneous adverse event reporting, knowledge surveys, and systems that track stakeholder completion of certain activities, such as enrollment and documentation of safe use conditions. To improve how REMS are assessed, FDA is considering additional areas for measurement and additional methods to measure the impact of REMS.

1. Should FDA routinely ask sponsors to assess the overall impact of their REMS on prescriber, dispenser, and patient burden, and/or access to the drug? If so, how could drug manufacturers assess the REMS impact on access and burden?

2. What methods might be used to separate the impact of a REMS program from that of other related risk management activities? Without having a control group, how should FDA interpret and act on REMS assessment information?

3. It is possible to interpret evidence of sustained REMS effectiveness to mean that the REMS should be maintained indefinitely, but such evidence may also suggest that safe use of the drug is now ingrained in the health care system and that the REMS can be modified or eliminated. What evidence could help FDA determine whether a drug would continue to be used safely if the REMS were modified or released?

IV. Attendance and Registration

The FDA Conference Center at the White Oak location is a federal facility with security procedures and limited seating. Attendance is free and will be on a first come, first served basis. Individuals who wish to present at the public meeting must register on or before July 10, 2013, throughhttp://remsmeeting.eventbrite.comand provide complete contact information, including name, title, affiliation, address, email, and phone number. In section III of this document, FDA has included questions for comment. You should identify the questions you wish to address in your presentation, so that FDA can consider that in organizing the presentations. FDA will do its best to accommodate requests to speak, and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. An agenda will be available approximately 2 weeks before the meeting athttp://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm351029.htm.

If you need special accommodations because of disability, please contact Adam Kroetsch (seeFOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

A live Web cast of this meeting will be viewable athttps://collaboration.fda.gov/remsjuly2013/on the day of the meeting. A video record of the meeting will be available at the same Web address for 1 year.

V. Comments

Interested persons may submit either electronic comments regarding this document tohttp://www.regulations.govor written comments to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. To ensure consideration, submit comment by (seeDATES). Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket athttp://www.regulations.gov.

VI. Transcripts

Please be advised that as soon as a transcript is available, it will be accessible athttp://www.regulations.gov.It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee:Science Board to the Food and Drug Administration (Science Board).

General Function of the Committee:The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs.

Date and Time:The meeting will be held on Monday, June 24, 2013, from approximately 1 p.m. to 3:45 p.m.

Location:Food and Drug Administration, White Oak Bldg. 31, Rm. 1503, section A, 10903 New Hampshire Ave., Silver Spring, MD 20993. This meeting will be held via teleconference (301-796-4100 or 866-901-3913; passcode: 665127) and via Adobe Connect (https://collaboration.fda.gov/scienceboard). Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:http://www.fda.gov/AdvisoryCommittees/default.htm;under the heading “Resources for You,” click on “Public Meetings at the FDA White Oak Campus.” Please note that visitors to the White Oak Campus must enter through Building 1.

Contact Person:Martha Monser, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, White Oak Bldg. 32, Rm. 4286, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4627, email:martha.monser@fda.hhs.gov,or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in theFederal Registerabout last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site athttp://www.fda.gov/AdvisoryCommittees/default.htmand scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Agenda:On June 24, 2013, the Science Board will be provided draft final reports from the Center for Devices and Radiological Health Research Review subcommittee, and the Global Health subcommittee. A revised charge (initially proposed at the October 3, 2012, Science Board meeting) regarding a new subcommittee to evaluate the Agency's continuing work to address the challenges identified in the Science Board's 2007 “Science and Mission at Risk” Report will be presented.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.Scroll down to the appropriate advisory committee meeting link.

Procedure:Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before Monday, June 17, 2013. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 1:45 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before Friday, June 7, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by Monday, June 10, 2013.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Martha Monser, at least 7 days in advance of the meeting.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee:Center for Scientific Review Special Emphasis Panel; Member Conflict: Neurodegeneration.

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee:National Heart, Lung, and Blood Institute Special Emphasis Panel; Pathway to Independence—K22/K99 Applications.